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Hysingla ER hydrocodone bitartrate 30 mg Tablet, Extended Release, 60-count — NDC 59011-0272-60 package photo

Hysingla ER hydrocodone bitartrate 30 mg Tablet, Extended Release, 60-count

by Knoa Pharma LLC · 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-272-60)
NDC 59011-0272-60
🏷️ FDA NDC (as labeled) 59011-272-60 billing pads the product segment with a zero
Rx only Brand On market CII 🛡 REMS
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 59011-272-60
Product NDC 59011-272
11-digit billing NDC 59011027260
NCPDP billing unit EA — each (per item)
RxCUI 1595730, 1595736, 1595740, 1595742, 1595746, 1595748, 1595752, 1595754,
UNII NO70W886KK
UPC 0359011273607, 0359011276608, 0359011272600, 0359011274604 +2 more
Application # NDA206627
SPL Set ID b7d23ac2-e776-9f62-3290-c64c2d6eb353
Established class (EPC) Opioid Agonist
Mechanism of action Opioid Agonists
DEA schedule CII
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-01-15
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance HYDROCODONE BITARTRATE
GPI-14 6510003010A820
GPI class Hysingla ER
GCN Seq No 073177
GCN 37541
HICL code 001731
Ingredient (HICL) Hydrocodone Bitartrate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3A
Therapeutic class — specific (HIC3) Opioid Analgesics
AHFS code 28:08.08.00
AHFS class Opioid Agonists (28:08)
FDB label name HYSINGLA ER 30 MG TABLET
FDB brand name Hysingla Er
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 59011-272-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59011-0272-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Opium alkaloids and derivatives
How it works Opioid Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerKnoa Pharma LLC
Application holderKNOA PHARMA LLC
FDA applicationNDA206627 (NDA)
Labeler code59011
First marketedJan 2015
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio20 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name HYSINGLA ER 30 MG TABLET Ingredient Hydrocodone Bitartrate
📖 What it is MedlinePlus · NLM

Hydrocodone is used to relieve severe pain. Hydrocodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain. This monograph only includes information about the use of hydrocodone alone. If you are taking a hydrocodone combination product, be sure to read information about all the ingredients in the hydrocodone-combination monograph and ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • This extended-release form of hydrocodone is designed for pain that is severe and present all day, every day — the kind that needs steady, around-the-clock control rather than occa...
  • Why did my doctor prescribe this instead of a regular pain pill?
  • Absolutely not — and this is one of the most important things to know. These products are engineered to release hydrocodone slowly over many hours. If you crush, chew, break, or di...
  • Can I crush or cut the tablet or capsule to make it easier to swallow?
📖 Read our full Hydrocodone guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow / Green / Gray / White / Pink / Blue
ShapeRound
ImprintHYD;100
Size12 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $19.389 $1,163.34 / 60 tablets
Medicaid paysCMS SDUD · 12 mo $18.10 $1,085.72 / 60 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Jan 2026 Jun 2026 Aug 2026 $19.441 $15.257
▲ Up 27% over the last 7 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hysingla ER 30 mgthis 59011-0272-60 Knoa 60 tablets $19.389 AB Availability likely —
Hydrocodone Bitartrate 30 mg 47781-0393-60 Alvogen 60 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2014
First FDA approval
Nov 2014
📍
2026
Currently FDA-listed
12 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 20, 2014 AB TE-rated RLD RS ⏳ ~5.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8808740 — method of use (U-1556)
US 8808740 — method of use (U-1556)
US 9095614 — method of use (U-1556)
US 9095614 — method of use (U-1556)
US 9545380 — method of use (U-1556)
US 9545380 — method of use (U-1556)
US 9545380 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9492390 — method of use (U-1556)
US 9492390 — method of use (U-1556)
US 8808740 — method of use (U-1556)
US 8808740 — method of use (U-1556)
US 8808740 — method of use (U-1556)
US 8808740 — method of use (U-1556)
US 9095614 — method of use (U-1556)
US 9095614 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9492390 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9492390 — method of use (U-1556)
US 9492390 — method of use (U-1556)
US 9492390 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9545380 — method of use (U-1556)
US 9545380 — method of use (U-1556)
US 8808740 — method of use (U-1556)
US 9492390 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9545380 — method of use (U-1556)
US 9545380 — method of use (U-1556)
US 9095614 — method of use (U-1556)
US 9095614 — method of use (U-1556)
US 9095614 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 9770416 — drug product
US 9861584 — drug product
US 9872837 — drug product
US 9872837 — drug product
US 9750703 — drug product
US 9492389 — drug product
US 9084816 — drug product
US 9492389 — drug product
US 9750703 — drug product
US 9763933 — drug product
US 9095615 — drug product
US 9872837 — drug product
US 9872837 — drug product
US 9486413 — drug product
US 9095615 — drug product
US 9861584 — drug product
US 9750703 — drug product
US 9572779 — drug product
US 9775809 — drug product
US 9492389 — drug product
US 9486412 — drug product
US 9861584 — drug product
US 9861584 — drug product
US 9486413 — drug product
US 9861584 — drug product
US 9763933 — drug product
US 9095615 — drug product
US 9750703 — drug product
US 9775809 — drug product
US 9572779 — drug product
US 9763933 — drug product
US 11304908 — drug product
US 11304908 — drug product
US 9763933 — drug product
US 9084816 — drug product
US 9492389 — drug product
US 9775809 — drug product
US 11304908 — drug product
US 9084816 — drug product
US 9486412 — drug product
US 9492389 — drug product
US 9763933 — drug product
US 9770416 — drug product
US 9095615 — drug product
US 9572779 — drug product
US 9486413 — drug product
US 9486412 — drug product
US 9572779 — drug product
US 9572779 — drug product
US 9084816 — drug product
US 9770416 — drug product
US 9572779 — drug product
US 9770416 — drug product
US 9775809 — drug product
US 9492389 — drug product
US 9775809 — drug product
US 9763933 — drug product
US 9750703 — drug product
US 9572779 — drug product
US 9872837 — drug product
US 9486413 — drug product
US 9750703 — drug product
US 9492389 — drug product
US 9486412 — drug product
US 9486413 — drug product
US 9486413 — drug product
US 9486412 — drug product
US 9095615 — drug product
US 9486412 — drug product
US 9486412 — drug product
US 11304908 — drug product
US 9770416 — drug product
US 9770416 — drug product
US 9095615 — drug product
US 9872837 — drug product
US 9084816 — drug product
US 9861584 — drug product
US 11304908 — drug product
US 9763933 — drug product
US 9084816 — drug product
US 9770416 — drug product
US 9095615 — drug product
US 9750703 — drug product
US 9861584 — drug product
US 9872837 — drug product
US 9775809 — drug product
US 9084816 — drug product
US 11304908 — drug product
US 9486413 — drug product
US 9775809 — drug product
US 11304908 — drug product
2014 2016 2018 2020 2022 2024 2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (133)
PatentTypeUse codeExpires
US 8808740 ↗ Method of use U-1556 Dec 21, 2031
US 8808740 ↗ Method of use U-1556 Dec 21, 2031
US 9095614 ↗ Method of use U-1556 Aug 24, 2027
US 9095614 ↗ Method of use U-1556 Aug 24, 2027
US 9545380 ↗ Method of use U-1556 Aug 24, 2027
US 9545380 ↗ Method of use U-1556 Aug 24, 2027
US 9545380 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9492390 ↗ Method of use U-1556 Aug 24, 2027
US 9492390 ↗ Method of use U-1556 Aug 24, 2027
US 8808740 ↗ Method of use U-1556 Dec 21, 2031
US 8808740 ↗ Method of use U-1556 Dec 21, 2031
US 8808740 ↗ Method of use U-1556 Dec 21, 2031
US 8808740 ↗ Method of use U-1556 Dec 21, 2031
US 9095614 ↗ Method of use U-1556 Aug 24, 2027
US 9095614 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9492390 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9492390 ↗ Method of use U-1556 Aug 24, 2027
US 9492390 ↗ Method of use U-1556 Aug 24, 2027
US 9492390 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9545380 ↗ Method of use U-1556 Aug 24, 2027
US 9545380 ↗ Method of use U-1556 Aug 24, 2027
US 8808740 ↗ Method of use U-1556 Dec 21, 2031
US 9492390 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9545380 ↗ Method of use U-1556 Aug 24, 2027
US 9545380 ↗ Method of use U-1556 Aug 24, 2027
US 9095614 ↗ Method of use U-1556 Aug 24, 2027
US 9095614 ↗ Method of use U-1556 Aug 24, 2027
US 9095614 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 9861584 ↗ Drug product — Dec 21, 2031
US 9872837 ↗ Drug product — Dec 21, 2031
US 9872837 ↗ Drug product — Dec 21, 2031
US 9750703 ↗ Drug product — Dec 21, 2031
US 9492389 ↗ Drug product — Aug 24, 2027
US 9084816 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 9750703 ↗ Drug product — Dec 21, 2031
US 9763933 ↗ Drug product — Aug 24, 2027
US 9095615 ↗ Drug product — Aug 24, 2027
US 9872837 ↗ Drug product — Dec 21, 2031
US 9872837 ↗ Drug product — Dec 21, 2031
US 9486413 ↗ Drug product — Aug 24, 2027
US 9095615 ↗ Drug product — Aug 24, 2027
US 9861584 ↗ Drug product — Dec 21, 2031
US 9750703 ↗ Drug product — Dec 21, 2031
US 9572779 ↗ Drug product — Dec 21, 2031
US 9775809 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 9486412 ↗ Drug product — Aug 24, 2027
US 9861584 ↗ Drug product — Dec 21, 2031
US 9861584 ↗ Drug product — Dec 21, 2031
US 9486413 ↗ Drug product — Aug 24, 2027
US 9861584 ↗ Drug product — Dec 21, 2031
US 9763933 ↗ Drug product — Aug 24, 2027
US 9095615 ↗ Drug product — Aug 24, 2027
US 9750703 ↗ Drug product — Dec 21, 2031
US 9775809 ↗ Drug product — Aug 24, 2027
US 9572779 ↗ Drug product — Dec 21, 2031
US 9763933 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 9763933 ↗ Drug product — Aug 24, 2027
US 9084816 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 9775809 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 9084816 ↗ Drug product — Aug 24, 2027
US 9486412 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 9763933 ↗ Drug product — Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 9095615 ↗ Drug product — Aug 24, 2027
US 9572779 ↗ Drug product — Dec 21, 2031
US 9486413 ↗ Drug product — Aug 24, 2027
US 9486412 ↗ Drug product — Aug 24, 2027
US 9572779 ↗ Drug product — Dec 21, 2031
US 9572779 ↗ Drug product — Dec 21, 2031
US 9084816 ↗ Drug product — Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 9572779 ↗ Drug product — Dec 21, 2031
US 9770416 ↗ Drug product — Aug 24, 2027
US 9775809 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 9775809 ↗ Drug product — Aug 24, 2027
US 9763933 ↗ Drug product — Aug 24, 2027
US 9750703 ↗ Drug product — Dec 21, 2031
US 9572779 ↗ Drug product — Dec 21, 2031
US 9872837 ↗ Drug product — Dec 21, 2031
US 9486413 ↗ Drug product — Aug 24, 2027
US 9750703 ↗ Drug product — Dec 21, 2031
US 9492389 ↗ Drug product — Aug 24, 2027
US 9486412 ↗ Drug product — Aug 24, 2027
US 9486413 ↗ Drug product — Aug 24, 2027
US 9486413 ↗ Drug product — Aug 24, 2027
US 9486412 ↗ Drug product — Aug 24, 2027
US 9095615 ↗ Drug product — Aug 24, 2027
US 9486412 ↗ Drug product — Aug 24, 2027
US 9486412 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 9095615 ↗ Drug product — Aug 24, 2027
US 9872837 ↗ Drug product — Dec 21, 2031
US 9084816 ↗ Drug product — Aug 24, 2027
US 9861584 ↗ Drug product — Dec 21, 2031
US 11304908 ↗ Drug product — Aug 24, 2027
US 9763933 ↗ Drug product — Aug 24, 2027
US 9084816 ↗ Drug product — Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 9095615 ↗ Drug product — Aug 24, 2027
US 9750703 ↗ Drug product — Dec 21, 2031
US 9861584 ↗ Drug product — Dec 21, 2031
US 9872837 ↗ Drug product — Dec 21, 2031
US 9775809 ↗ Drug product — Aug 24, 2027
US 9084816 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 9486413 ↗ Drug product — Aug 24, 2027
US 9775809 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
Common questions
Is there a generic version of HYSINGLA ER 30 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for HYSINGLA ER 30 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 59011-0272-60, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
437
Units reimbursed last 4 qtrs
14.1K
Gross reimbursed last 4 qtrs
$255.8K
Avg / prescription
$585.31
Avg / unit
$18.0954
Latest quarter Q4 2025
107Rx
Medicaid pays / ea
$18.0954
gross reimbursed
vs
NADAC / ea
$19.3890
acquisition cost
=
Spread
−$1.2936
-7% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
78% FFS 22% MCO
Fee-for-service · 342 Rx Managed care · 95 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 4,957 units · 83.9 per 100k residents WI Michigan: no data reported MI New York: 2,107 units · 10.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 435 units · 3.5 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 765 units · 5.9 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 3,504 units · 9.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 336 units · 9.3 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 2,031 units · 18.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.583.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Wisconsin 83.9 /100k
2 North Carolina 18.7 /100k
3 New York 10.8 /100k
4 Connecticut 9.3 /100k
5 California 9.0 /100k
6 Pennsylvania 5.9 /100k
7 Illinois 3.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Hysingla ER — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Hysingla ER. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.12M
Claims incl. refills
4.5K
Beneficiaries
1.8K
Spend / beneficiary
$1,778.43
Spend / claim
$700.68
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🛡
This drug has a REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It may require enrollment, counseling, or monitoring to manage a serious risk. See the boxed warning & full label below, and REMS@FDA ↗.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Hysingla ER (this brand).

Top reported reactions

Death11,933
Drug Dependence10,363
Overdose9,664
Toxicity To Various Agents9,510
Pain7,319
Emotional Distress6,721
Drug Withdrawal Syndrome5,578

Age at onset

Neonate232
Infant57
Child46
Adolescent9
Adult700
Elderly203

Reporter sex

43,199 reports
Male · 48%
Female · 52%
Unknown · 0%

Serious outcomes

Hospitalization4,428
Life-threatening184
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 6,113 201
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59011-0272-60 You're viewing this 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-272-60) 2015-01-15 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~3 min read ▾

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYSINGLA ER Addiction, Abuse, and Misuse Because the use of HYSINGLA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of HYSINGLA ER, especially during initiation or following a dosage increase.

To reduce the risk of respiratory depression, proper dosing and titration of HYSINGLA ER are essential. Instruct patients to swallow HYSINGLA ER tablets whole; crushing, chewing, or dissolving HYSINGLA ER tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone [see Warnings and Precautions (5.2) ] . Accidental Ingestion Accidental ingestion of even one dose of HYSINGLA ER, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions (5.2) ] .

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of HYSINGLA ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3) , Drug Interactions (7) ]. Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated.

Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4) ] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.5) ]. Cytochrome P450 3A4 Interaction The concomitant use of HYSINGLA ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression.

In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Regularly evaluate patients receiving HYSINGLA ER and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.6) , Drug Interactions (7) , and Clinical Pharmacology (12.3) ]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYSINGLA ER See full prescribing information for complete boxed warning.

HYSINGLA ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing, and reassess regularly for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur, especially upon initiation or following a dosage increase.

To reduce the risk of respiratory depression, proper dosing and titration of HYSINGLA ER are essential. Instruct patients to swallow HYSINGLA ER whole to avoid exposure to a potentially fatal dose of hydrocodone. ( 5.2 ) Accidental ingestion of HYSINGLA ER, especially by children, can result in fatal overdose of hydrocodone.

( 5.2 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatmen…

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE HYSINGLA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including HYSINGLA ER, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

HYSINGLA ER is not indicated as an as-needed (prn) analgesic. HYSINGLA ER is an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including HYSINGLA ER, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

( 1 , 5.1 ) HYSINGLA ER is not indicated as an as-needed (prn) analgesic. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION HYSINGLA ER should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) Daily doses of HYSINGLA ER greater than or equal to 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. ( 2.1 ) Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

( 2.1 ) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( 2.1 ). Reserve titration to higher doses of HYSINGLA ER for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5.1 ) Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse.

( 2.1 , 5.1 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with HYSINGLA ER. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.2 ) HYSINGLA ER is administered orally once daily (every 24 hours).

( 2.1 ) Instruct patients to swallow HYSINGLA ER intact, and not to crush, chew, or dissolve the tablets (risk of potentially fatal overdose). ( 2.1 , 5.1 ) Instruct patients to take tablets one at a time, with enough water to ensure complete swallowing immediately after placing in the mouth ( 2.1 , 5.13 ) For patients who are not opioid tolerant, initiate with 20 mg tablets orally every 24 hours. ( 2.3 ) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with HYSINGLA ER, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose.

( 2.2 , 5.1 , 5.2 , 5.3 ) To convert to HYSINGLA ER from another opioid, follow the conversion instructions to obtain an estimated dose. ( 2.3 ) Dose titration of HYSINGLA ER may occur every 3 to 5 days ( 2.4 ) Periodically reassess patients receiving HYSINGLA ER to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. ( 2.4 ) Patients with Severe Hepatic Impairment : Initiate dosing with one half of the recommended starting dosage and titrate carefully.

Regularly evaluate for respiratory depression, sedation, and hypotension. ( 2.5 ) Patients with Moderate to Severe Renal Impairment and End-Stage Renal Disease : Initiate dosing at one half the recommended starting dosage and titrate carefully. Regularly evaluate for signs of respiratory depression, sedation, and hypotension.

( 2.6 ) Do not rapidly reduce or abruptly discontinue HYSINGLA ER in a physically-dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ( 2.7 , 5.16 )

2.1Important Dosage and Administration Instructions HYSINGLA ER should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. Daily doses of HYSINGLA ER greater than or equal to 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day,…

💊 Dosage Forms and Strengths 94 words ▾

3 DOSAGE FORMS AND STRENGTHS 20 mg film-coated extended-release tablets (round, green-colored, bi-convex tablets printed with "HYD 20") 30 mg film-coated extended-release tablets (round, yellow-colored, bi-convex tablets printed with "HYD 30") 40 mg film-coated extended-release tablets (round, grey-colored, bi-convex tablets printed with "HYD 40") 60 mg film-coated extended-release tablets (round, beige-colored, bi-convex tablets printed with "HYD 60") 80 mg film-coated extended-release tablets (round, pink-colored, bi-convex tablets printed with "HYD 80") 100 mg film-coated extended-release tablets (round, blue-colored, bi-convex tablets printed with "HYD 100") Extended-release tablets: 20, 30, 40, 60, 80, 100 ( 3 )

⛔ Contraindications 115 words ▾

4 CONTRAINDICATIONS HYSINGLA ER is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.13 , 5.14) ] Hypersensitivity to hydrocodone or any component of HYSINGLA ER. Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) Hypersensitivity to hydrocodone or to any other components of HYSINGLA ER ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation. ( 5.7 ) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate, particularly during initiation and titration.

( 5.8 ) Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 ) Severe Hypotension : Regularly evaluate during dosage initiation and titration. Avoid use of HYSINGLA ER in patients with circulatory shock.

( 5.10 ) QTc Prolongation: Avoid use in patients with congenital long QTc syndrome. In patients who develop QTc prolongation, consider reducing the dose. ( 5.11 , 12.2 ) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness : Monitor for sedation and respiratory depression.

Avoid use of HYSINGLA ER in patients with circulatory shock. ( 5.12 ) Risk of Obstruction in Patients who have Difficulty Swallowing or have Underlying GI Disorders that may Predispose them to Obstruction : Consider use of an alternative analgesic. ( 5.14 )

5.1Addiction, Abuse, and Misuse HYSINGLA ER contains hydrocodone, a Schedule II controlled substance. As an opioid, HYSINGLA ER exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed HYSINGLA ER.

Addiction can occur at recommended doses and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see Adverse Reactions (6.2) ].

Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing HYSINGLA ER, and reassess all patients receiving HYSINGLA ER for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the prescribing of HYSINGLA ER for the proper management of pain in any given patient.

Patients at increased risk may be prescribed opioids such as HYSINGLA ER, but use in such patients necessitates intensive counseling about the risks and proper use of HYSINGLA ER along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ]. Abuse or misuse of HYSINGLA ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the hydrocodone and can result in overdose and death [see Drug Abuse and Dependence (9.2) , Overdosage (10) ] .

Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when prescribing or dispensing HYSINGLA ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and the proper disposal of unused drug.

Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

5.2Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interactions with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Severe Hypotension [see Warnings and Precautions (5.10) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13 , 5.14) ] Seizures [see Warnings and Precautions (5.15) ] Withdrawal [see Warnings and Precautions (5.16) ] Most common treatment-emergent adverse events (incidence ≥ 5%) are constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Knoa Pharma LLC at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 1,827 patients were treated with HYSINGLA ER in controlled and open-label chronic pain clinical trials. Five hundred patients were treated for 6 months and 364 patients were treated for 12 months.

The clinical trial population consisted of patients who were not opioid tolerant and opioid-experienced patients with persistent moderate to severe chronic pain. The common adverse reactions (≥2%) reported by patients in clinical trials comparing HYSINGLA ER (20-120 mg/day) with placebo are shown in Table 2 below: Table 2: Adverse Reactions Reported in ≥2% of Patients during the Open-Label Titration Period and Double-Blind Treatment Period: Patients Who Were Not Opioid Tolerant and Opioid-Experienced Patients Open-label Titration Period Double-blind Treatment Period MedDRA Preferred Term (N=905) (%) Placebo (N=292) (%) HYSINGLA ER (N=296) (%) Nausea 16 5 8 Constipation 9 2 3 Vomiting 7 3 6 Dizziness 7 2 3 Headache 7 2 2 Somnolence 5 1 1 Fatigue 4 1 1 Pruritus 3 <1 0 Tinnitus 2 1 2 Insomnia 2 2 3 Decreased appetite 1 1 2 Influenza 1 1 3 The adverse reactions seen in controlled and open-label chronic pain studies are presented below in the following manner: most common (≥5%), common (≥1% to <5%), and less common (<1%).

The most common adverse reactions (≥5%) reported by patients treated with HYSINGLA ER in the chronic pain clinical trials were constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, somnolence. The common (≥1% to <5%) adverse events reported by patients treated with HYSINGLA ER in the chronic pain clinical trials organized by MedDRA (Medical Dictionary for Regulatory Activities) System Organ Class were: Ear and labyrinth disorders tinnitus Gastrointestinal disorders abdominal pain, abdominal pain upper, diarrhea, dry mouth, dyspepsia, gastroesophageal reflux disease General disorders and administration site conditions chest pain, chills, edema peripheral, pain, pyrexia Infections and infestations bronchitis, gastroenteritis, gastroenteritis viral, influenza, nasopharyngitis, sinusitis, urinary tract infection Injury, poisoning and procedural complications fall, muscle strain Metabolism and nutrition disorders decreased appetite Musculoskeletal and connective tissue disorders arthralgia, back pain, muscle spasms, musculoskeletal pain, myalgia, pain in extremity Nervous system disorders lethargy, migraine, sedation Psychiatric disorders anxiety, depression, insomnia Respiratory, thoracic and mediastinal disorders cough, nasal congestion, oropharyngeal pain Skin and subcutaneous tissue disorde…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with HYSINGLA ER. Table 3: Clinically Significant Drug Interactions with HYSINGLA ER Inhibitors of CYP3A4 Clinical Impact: The concomitant use of HYSINGLA ER and CYP3A4 inhibitors can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of HYSINGLA ER and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of HYSINGLA ER is achieved [see Warnings and Precautions (5.6) ] .

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease [see Clinical Pharmacology (12.3) ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to hydrocodone. Intervention: If concomitant use is necessary, consider dosage reduction of HYSINGLA ER until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation.

If a CYP3A4 inhibitor is discontinued, consider increasing the HYSINGLA ER dosage until stable drug effects are achieved. Assess for signs of opioid withdrawal. Examples Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir).

CYP3A4 Inducers Clinical Impact: The concomitant use of HYSINGLA ER and CYP3A4 inducers can decrease the plasma concentration of hydrocodone [see Clinical Pharmacology (12.3) ] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone [see Warnings and Precautions (5.6) ] . After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [see Clinical Pharmacology (12.3) ] , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

Intervention: If concomitant use is necessary, consider increasing the HYSINGLA ER dosage until stable drug effects are achieved. Evaluate for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider HYSINGLA ER dosage reduction and evaluate patients at frequent intervals for signs of respiratory depression and sedation.

Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions (5.3) ]. Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2) , Warnings and Precautions (5.1 , 5.2 , 5.3) ].

Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome . Intervention: If concomitant use is warranted, frequently evaluate the patient, particularly during treatment initiation and dose adjustment.

Discontinue HYSINGLA ER if serotonin syndrome is suspected. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : May cause fetal harm. ( 8.1 ) Lactation : Not recommended. ( 8.2 )

8.1Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4) ] . Available data with HYSINGLA ER in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies with hydrocodone in rats and rabbits no embryotoxicity or teratogenicity was observed.

However, reduced pup survival rates, reduced fetal/pup body weights, and delayed ossification were observed at doses causing maternal toxicity. In all of the studies conducted, the exposures in animals were less than the human exposure [see Data ] . The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/neonatal adverse reactions Use of opioid analgesics for extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.4) ] .

Labor and Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. HYSINGLA ER is not recommended for use in pregnant women during or immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate.

Opioid analgesics, including HYSINGLA ER, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

Data Animal Data No evidence of embryotoxicity or teratogenicity was observed after oral administration of hydrocodone throughout the period of organogenesis in rats and rabbits at doses up to 30 mg/kg/day (approximately 0.1 and 0.3 times, respectively, the human hydrocodone dose of 120 mg/day based on AUC exposure comparisons). However, in these studies, reduced fetal body weights and delayed ossification were observed in rat at 30 mg/kg/day and reduced fetal body weights were observed in rabbits at 30 mg/kg/day (approximately 0.1 and 0.3 times, respectively, the human hydrocodone dose of 120 mg/day based on AUC exposure comparisons).

In a pre- and post-natal development study pregnant rats were administered oral hydrocodone throughout the period of gestation and lactation. At a dose of 30 mg/kg/day decreased pup viability, pup survival indices, litter size and pup body weight were observed. This dose is approximately 0.1 times the human hydrocodone dose of 120 mg/day based on AUC exposure comparisons.

8.2Lactation Risk Summary Hydrocodone is present in human milk. A published lactation study reports variable concentrations of…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4) ] . Available data with HYSINGLA ER in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies with hydrocodone in rats and rabbits no embryotoxicity or teratogenicity was observed.

However, reduced pup survival rates, reduced fetal/pup body weights, and delayed ossification were observed at doses causing maternal toxicity. In all of the studies conducted, the exposures in animals were less than the human exposure [see Data ] . The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/neonatal adverse reactions Use of opioid analgesics for extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.4) ] .

Labor and Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. HYSINGLA ER is not recommended for use in pregnant women during or immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate.

Opioid analgesics, including HYSINGLA ER, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

Data Animal Data No evidence of embryotoxicity or teratogenicity was observed after oral administration of hydrocodone throughout the period of organogenesis in rats and rabbits at doses up to 30 mg/kg/day (approximately 0.1 and 0.3 times, respectively, the human hydrocodone dose of 120 mg/day based on AUC exposure comparisons). However, in these studies, reduced fetal body weights and delayed ossification were observed in rat at 30 mg/kg/day and reduced fetal body weights were observed in rabbits at 30 mg/kg/day (approximately 0.1 and 0.3 times, respectively, the human hydrocodone dose of 120 mg/day based on AUC exposure comparisons).

In a pre- and post-natal development study pregnant rats were administered oral hydrocodone throughout the period of gestation and lactation. At a dose of 30 mg/kg/day decreased pup viability, pup survival indices, litter size and pup body weight were observed. This dose is approximately 0.1 times the human hydrocodone dose of 120 mg/day based on AUC exposure comparisons.

🧒 Pediatric Use 65 words ▾

8.4Pediatric Use The safety and effectiveness of HYSINGLA ER in pediatric patients have not been established. HYSINGLA ER gradually forms a viscous hydrogel (i.e., a gelatinous mass) when exposed to water or other fluids. Pediatric patients may be at increased risk of esophageal obstruction, dysphagia, and choking because of a smaller gastrointestinal lumen if they ingest HYSINGLA ER [see Warnings and Precautions (5.13) ].

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use In a controlled pharmacokinetic study, elderly subjects (greater than 65 years) compared to young adults had similar plasma concentrations of hydrocodone [see Clinical Pharmacology (12.3) ] . Of the 1827 subjects exposed to HYSINGLA ER in the pooled chronic pain studies, 241 (13%) were age 65 and older (including those age 75 and older), while 42 (2%) were age 75 and older. In clinical trials with appropriate initiation of therapy and dose titration, no untoward or unexpected adverse reactions were seen in the elderly patients who received HYSINGLA ER.

In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.

Titrate the dosage of HYSINGLA ER slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.8) ] . Hydrocodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE Clinical Presentation Acute overdosage with hydrocodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2) ] . Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication.

Treatment of Overdose In case of overdose, priorities are the re-establishment of a patent airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias will require advanced life support measures.

For clinically significant respiratory or circulatory depression secondary to hydrocodone overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone in HYSINGLA ER, carefully monitor the patient until spontaneous respiration is reliably re-established. HYSINGLA ER will continue to release hydrocodone and add to the hydrocodone load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring.

If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed by the product's prescribing information. In an individual physically dependent on opioids, administration of the recommended dose of the opioid overdose reversal agent will precipitate an acute withdrawal syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the reversal agent administered.

If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the reversal agent should be initiated with care and by titration with smaller than usual doses of the reversal agent.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Hydrocodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone.

Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

12.2Pharmacodynamics Cardiac Electrophysiology QTc interval prolongation was studied in a double-blind, placebo- and positive-controlled 3-treatment parallel-group, dose-escalating study of HYSINGLA ER in 196 healthy subjects. QTc interval prolongation was observed following HYSINGLA ER 160 mg per day. The maximum mean (90% upper confidence bound) difference in the QTc interval between HYSINGLA ER and placebo (after baseline-correction) at steady state was 6 (9) milliseconds, 7 (10) milliseconds, and 10 (13) milliseconds at HYSINGLA ER doses of 80 mg, 120 mg and 160 mg respectively.

For clinical implications of the prolonged QTc interval, [see Warnings and Precautions (5.11) ]. Effects on the Central Nervous System Hydrocodone produces respiratory depression by direct action on brainstem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.

Hydrocodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Overdosage (10) ] .

Effects on the Gastrointestinal Tract and Other Smooth Muscle Hydrocodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm, resulting in constipation.

Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, transient elevations in serum amylase, and opioid-induced esophageal dysfunction (OIED). Effects on the Cardiovascular System Hydrocodone produces peripheral vasodilation, which may result in orthostatic hypotension or syncope Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see Adverse Reactions (6.2) ] .

They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Use of opioids for an extended period of time may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions (6.2) ] .

Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The c…

🧬 Mechanism of Action 113 words ▾

12.1Mechanism of Action Hydrocodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone.

Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

📦 How Supplied / Storage and Handling 217 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, bi-convex tablets printed with "HYD 20" and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-271-60). HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 30 mg are round, yellow-colored, bi-convex tablets printed with "HYD 30" and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-272-60). HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 40 mg are round, grey-colored, bi-convex tablets printed with "HYD 40" and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-273-60).

HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 60 mg are round, beige-colored, bi-convex tablets printed with "HYD 60" and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-274-60). HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 80 mg are round, pink-colored, bi-convex tablets printed with "HYD 80" and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-275-60). HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 100 mg are round, blue-colored, bi-convex tablets printed with "HYD 100" and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-276-60).

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container, as defined by the USP. Store HYSINGLA ER securely and dispose of properly.

📦 Storage and Handling 32 words ▾

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container, as defined by the USP. Store HYSINGLA ER securely and dispose of properly.

📋 Description ~1 min read ▾

11 DESCRIPTION HYSINGLA ER (hydrocodone bitartrate) extended-release tablets are supplied in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg film-coated tablets for oral administration. The tablet strengths describe the amount of hydrocodone per tablet as the bitartrate salt. Hydrocodone bitartrate is an opioid agonist.

Its chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its structural formula is: Empirical formula: C 18 H 21 NO 3 ∙ C 4 H 6 O 6 ∙ 2½H 2 O; Molecular weight: 494.49. Hydrocodone bitartrate exists as fine white crystals or a crystalline powder.

It is affected by light. It is soluble in water, slightly soluble in alcohol, and insoluble in ether and chloroform. The 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg tablets contain the following inactive ingredients: Butylated Hydroxytoluene (BHT, an additive in Polyethylene Oxide), Hydroxypropyl Cellulose, Macrogol/PEG 3350, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Oxide, Polysorbate 80, Polyvinyl Alcohol, Talc, Titanium Dioxide, and Black Ink.

The 20 mg tablets also contain Iron Oxide Yellow and FD&C Blue #2 Aluminum Lake/Indigo Carmine Aluminum Lake. The 30 mg tablets also contain Iron Oxide Yellow. The 40 mg tablets also contain Iron Oxide Yellow, Iron Oxide Red, and Iron Oxide Black.

The 60 mg tablets also contain Iron Oxide Yellow and Iron Oxide Red. The 80 mg tablets also contain Iron Oxide Red. The 100 mg tablets also contain FD&C Blue #2 Aluminum Lake.

Black Ink Contains: Shellac Glaze (in Ethanol), Isopropyl Alcohol, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol and Ammonium Hydroxide. Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide) Storage and Disposal: Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store HYSINGLA ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving HYSINGLA ER unsecured can pose a deadly risk to others in the home [see Warnings and Precautions (5.1 , 5.2) , Drug Abuse and Dependence (9.2) ] .

Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused HYSINGLA ER should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.

Addiction, Abuse, and Misuse Inform patients that the use of HYSINGLA ER, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose or death [see Warnings and Precautions (5.1) ] . Instruct patients not to share HYSINGLA ER with others and to take steps to protect HYSINGLA ER from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting HYSINGLA ER or when the dosage is increased, and that it can occur even at recommended dosages.

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions (5.2) , Overdosage (10) ] . Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.2) ]. Interaction with Benzodiazepines and other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if HYSINGLA ER is used with benzodiazepines or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids), and not to use these concomitantly unless supervised by a health care provider [see Warnings and Precautions (5.3) , Drug Interactions (7) ].

Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.

Discuss with the patient the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program) [see Dosage and Administration (2.2) , Warnings and Precautions (5.3) ] . Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that effects of opioid overdose reversal agents like naloxone and nalmefene are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if an opioid overdose reversal agent is administered [see Overdosage (10) ] .

Advise patients and caregivers: how to treat with the opioid overdose reversal agent in the event of an opioid overdose. to tell fami…

💬 Medication Guide ~3 min read ▾

Medication Guide HYSINGLA ® ER (hye-SING-luh) (hydrocodone bitartrate) extended-release tablets, CII This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2026 HYSINGLA ER is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine, when other non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.

A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Not to be taken on an "as needed" basis.

Important information about HYSINGLA ER: Get emergency help or call 911 right away if you take too much HYSINGLA ER (overdose) . When you first start taking HYSINGLA ER, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse and opioid overdose.

Taking HYSINGLA ER with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone else your HYSINGLA ER. They could die from taking it.

Selling or giving away HYSINGLA ER is against the law. Store HYSINGLA ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take HYSINGLA ER if you have: severe asthma, trouble breathing, or other lung problems. a bowel blockage or have narrowing of the stomach or intestines.

Before taking HYSINGLA ER, tell your healthcare provider if you have a history of: head injury, seizures liver, kidney, thyroid problems problems urinating pancreas or gallbladder problems heart rhythm problems (long QT syndrome) abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems Tell your healthcare provider if you are: noticing your pain getting worse. If your pain gets worse after you take HYSINGLA ER, do not take more of HYSINGLA ER without first talking to your healthcare provider.

Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking HYSINGLA ER. pregnant or planning to become pregnant . Use of HYSINGLA ER for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. breastfeeding . Not recommended during treatment with HYSINGLA ER.

It may harm your baby. living in a household where there are small children or someone who has abused street or prescription drugs. taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking HYSINGLA ER with certain other medicines can cause serious side effects and could lead to death. When taking HYSINGLA ER: Do not change your dose.

Take HYSINGLA ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. Take your prescribed dose every 24 hours, at the same time every day.

Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time the next day. Swallow HYSINGLA ER whole.

Do not cut, break, chew, crush, dissolve, snort, or inject HYSINGLA ER because this may cause you to overdose and die. HYSINGLA ER should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing it in your mouth to avoid choking on the tablet.

Call your healthcare provider if the dose you are taking does not control yo…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59011-0271-60 · Knoa 59011-0273-60 · Knoa →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.