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Nuzyra omadacycline 150 mg Tablet, Film Coated — NDC 71715-0002-27 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nuzyra omadacycline 150 mg Tablet, Film Coated — NDC 71715-002-27 (Billing 71715-0002-27)

by Paratek Pharmaceuticals, Inc. · 5 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Nuzyra omadacycline 150 mg Tablet, Film Coated from Paratek Pharmaceuticals, Inc., marketed since Feb 2019 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 71715-0002-27
🏷️ FDA NDC (as labeled) 71715-002-27 billing pads the product segment with a zero
This package
Contains6 tablet, film coated in 1 blister pack Medicaid pays$267.12 / unit · 12 mo Per package$8,013.52 / 30 tablets · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $270.69/unit — full pricing hub ↓
Main listing for product 71715-002 · Also comes in: 6 tablets 71715-002-21
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 71715-002-27 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71715 labeler · 002 product · 27 package
Package marketed since
Feb 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0371715001027, 0371715002215, 0371715002277
Medicaid fills, this package
1,288 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71715-002-27
Product NDC 71715-002
11-digit billing NDC 71715000227
NCPDP billing unit EA — each (per item)
RxCUI 2059274, 2059280, 2059288, 2059292
UNII 090IP5RV8F
UPC 0371715001027, 0371715002215, 0371715002277
Application # NDA209816
SPL Set ID 51591524-4703-44c6-8bde-dce3e6a463d1
Established class (EPC) Tetracycline-class Antibacterial
Chemical class Tetracyclines
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-02-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance OMADACYCLINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 04200050200320
GPI class Nuzyra
GCN Seq No 079052
GCN 45478
HICL code 045315
Ingredient (HICL) Omadacycline Tosylate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1C
Therapeutic class — specific (HIC3) Tetracycline Antibiotics
AHFS code 08:12.24.04
AHFS class Aminomethylcyclines
FDB label name NUZYRA 150 MG TABLET
FDB brand name Nuzyra
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079052
  • GCN: 45478
  • GPI-14 (Medi-Span): 04200050200320
  • HICL (First Databank): 045315
  • AHFS class code: 08:12.24.04
  • RxCUI (RxNorm): 2059274
Why two NDCs? The FDA registers this code as 71715-002-27 — 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 → 71715-0002-27. 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 Tetracycline-class Antibacterial class.

Pharmacologic class Tetracycline-class Antibacterial
Drug family (ATC) Tetracyclines
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.

Clinical

Label name NUZYRA 150 MG TABLET Ingredient Omadacycline Tosylate
📗 Our plain-language guide HelloPharmacist
  • It is an antibiotic for adults with community-acquired bacterial pneumonia or serious bacterial skin infections. It works only on bacteria, so it will not help a cold, flu or other...
  • Take them on an empty stomach. Fast for at least 4 hours first, then swallow the tablet with water. Afterward, wait 2 hours before eating or drinking anything but water. Wait 4 hou...
  • The most common are nausea, vomiting, diarrhea and headache. You might also have liver blood test changes or, with the IV form, irritation at the infusion site. Most of these are m...
  • Call if you have bad or watery diarrhea, which can happen even weeks after finishing. Also call right away for signs of an allergic reaction, such as a rash or trouble breathing. Y...
📖 Read our full Omadacycline guide →
4
Nutrient depletion considerations

Omadacycline (IV) may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Omadacycline (IV) nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $267.12 $8,013.52 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $270.69 $8,120.61 / 30 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71715-0002-21 71715-002-21 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK 2020-02-01 — Active
71715-0002-27 You're viewing this Main listing 5 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK 2020-02-01 — Active

In Medicaid, this is the most-dispensed pack of this product — about 80% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 5 blister pack in 1 carton / 6 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Nuzyra omadacycline 150 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nuzyra 150 mgthis 71715-0002-27 Paratek 6 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2018
First FDA approval
Oct 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 2, 2018 RLD RS ⏳ ~11.1 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 10111890 — method of use (U-2444)
US 9724358 — method of use (U-1569)
US 10383884 — method of use (U-2576)
US 10124014 — method of use (U-2449)
US 10835542 — method of use (U-2576)
US 9265740 — method of use (U-1569)
US 8383610 — drug substance
US 9314475 — drug product
Exclusivity M-320
Exclusivity NCE
Exclusivity GAIN
2018 2020 2022 2024 2026 2028 2030 2032 2034 2036
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 (8)
PatentTypeUse codeExpires
US 10111890 ↗ Method of use U-2444 Aug 3, 2037
US 9724358 ↗ Method of use U-1569 Mar 5, 2029
US 10383884 ↗ Method of use U-2576 Oct 31, 2037
US 10124014 ↗ Method of use U-2449 Mar 5, 2029
US 10835542 ↗ Method of use U-2576 Oct 31, 2037
US 9265740 ↗ Method of use U-1569 Oct 24, 2030
US 8383610 ↗ Drug substance — Sep 23, 2030
US 9314475 ↗ Drug product — Mar 18, 2031
FDA exclusivity
CodeWhat it grantsExpires
M-320New indication / labeling change (3-year)May 13, 2029
NCENew Chemical Entity (5-year)Oct 2, 2023
GAINQualified Infectious Disease Product (+5-year)Oct 2, 2028
Common questions
Is there a generic version of NUZYRA 150 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for NUZYRA 150 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2037 — an estimate, not a guaranteed launch date.
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.

What it looks like

Color yellow
ShapeDiamond
ImprintOMC;150
Size19 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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 G7515SW10N
    A waxy liquid derived from vegetable oil and fatty acids. It works as an emulsifier and solubilizer to help blend oil and water-based ingredients together and improve how the medicine dissolves and is absorbed in the body.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII TZX5469Z6I
    Sodium bisulfite is a chemical salt used as a preservative and antioxidant in medicines. It prevents discoloration and degradation of active ingredients, especially in liquid formulations and injectables.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • 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.

12 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.

Manufacturer & labeler

LabelerParatek Pharmaceuticals, Inc.
Application holderPARATEK PHARMACEUTICALS INC
FDA applicationNDA209816 (NDA)
Labeler code71715
First marketedFeb 2019
Product typeHuman Prescription Drug
Portfolio3 products on file

More NDCs from Paratek Pharmaceuticals, Inc. labeler code 71715

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms ( 1 ): Community-acquired bacterial pneumonia (CABP) ( 1.1 ) Acute bacterial skin and skin structure infections (ABSSSI) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.3 )

1.1Community-Acquired Bacterial Pneumonia NUZYRA is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae , Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae , Haemophilus parainfluenzae , Klebsiella pneumoniae, Legionella pneumophila , Mycoplasma pneumoniae, and Chlamydophila pneumoniae .

1.2Acute Bacterial Skin and Skin Structure Infections NUZYRA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis , Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus , S. intermedius , and S. constellatus ), Enterococcus faecalis , Enterobacter cloacae, and Klebsiella pneumoniae.

1.3Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dosage of NUZYRA in CABP and ABSSSI Adult Patients ( 2.2 , 2.3 ): Infection Loading Doses Maintenance Dose CABP NUZYRA Injection: Day 1: 200 mg by intravenous infusion over 60 minutes OR 100 mg by intravenous infusion over 30 minutes twice ( 2.2 ) OR NUZYRA Tablets: Day 1: 300 mg orally twice ( 2.2 ) NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily OR NUZYRA Tablets: 300 mg orally once daily ( 2.2 ) ABSSSI NUZYRA Injection: Day 1: 200 mg by intravenous infusion over 60 minutes OR 100 mg by intravenous infusion over 30 minutes twice ( 2.3 ) OR NUZYRA Tablets: Day 1 and Day 2: 450 mg orally once daily ( 2.3 ) NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily OR NUZYRA Tablets: 300 mg orally once daily ( 2.3 ) CABP and ABSSSI : Treatment duration is 7 to 14 days.

( 2.2 , 2.3 ) Fast for at least 4 hours and then take NUZYRA tablets with water. After oral dosing, no food or drink (except water) is to be consumed for 2 hours and no dairy products, antacids, or multivitamins for 4 hours. ( 2.1 ) See full prescribing information for the preparation of NUZYRA IV and other administration instructions.

( 2.1 , 2.5 )

2.1Important Administration Instructions NUZYRA for Injection : Do NOT administer NUZYRA for injection with any solution containing multivalent cations, e.g., calcium and magnesium, through the same intravenous line [see Drug Interactions (7.2) ] . Co-infusion with other medications has not been studied [see Dosage and Administration (2.5) ] . NUZYRA Tablets : Fast for at least 4 hours and then take with water.

After oral dosing, no food or drink (except water) is to be consumed for 2 hours and no dairy products, antacids, or multivitamins for 4 hours [see Drug Interactions (7.2) and Clinical Pharmacology (12.3) ].

2.2Recommended Dosage in Adults with Community-Acquired Bacterial Pneumonia (CABP) For treatment of adults with CABP the recommended dosage regimen (loading and maintenance) of NUZYRA is described in Table 1 below. Table 1: Recommended Dosage of NUZYRA in Adult CABP Patients Loading Doses Maintenance Dose Treatment Duration NUZYRA Injection: 200 mg by intravenous infusion over 60 minutes on day 1. OR 100 mg by intravenous infusion over 30 minutes, twice on day 1.

OR NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily. OR NUZYRA Tablets: 300 mg orally once daily. 7 to 14 Days NUZYRA Tablets: 300 mg orally twice on day 1.

2.3Recommended Dosage in Adults with Acute Bacterial Skin Structure and Skin Infections (ABSSSI) For treatment of adults with ABSSSI, the recommended dosage regimen (loading and maintenance) of NUZYRA is described in Table 2 below. Table 2: Recommended Dosage of NUZYRA in Adult ABSSSI Patients Loading Doses Maintenance Dose Treatment Duration NUZYRA Injection: 200 mg by intravenous infusion over 60 minutes on day 1. OR 100 mg by intravenous infusion over 30 minutes, twice on day 1.

OR NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily. OR NUZYRA Tablets: 300 mg orally once daily. 7 to 14 Days NUZYRA Tablets: 450 mg orally once a day on day 1 and day 2.

2.4Recommended Dosage Adjustments in Patients with Renal or Hepatic Impairment No dosage adjustment is warranted in patients with renal or hepatic impairment [see Clinical Pharmacology (12.3) ].

2.5Preparation and Administration of NUZYRA for Injection Intravenous Solution Reconstitution and Dilution : NUZYRA must be reconstituted and then further diluted under aseptic conditions. To prepare the required dose for intravenous infusion, reconstitute and dilute the appropriate number of vials, as determined from Table 3 below. Reconstitute each 100 mg vial of NUZYRA with 5 mL of Sterile Water, 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, for Injection.

Gently swirl the contents and let the vial stand until the cake has completely dissolved and any foam disperses. Do not shake the vial. T… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 123 words ▾

3 DOSAGE FORMS AND STRENGTHS For Injection : 100 mg of omadacycline (equivalent to 131 mg omadacycline tosylate) as a lyophilized powder in a single dose vial for reconstitution and further dilution before intravenous infusion ( 3.1 ) Tablets : 150 mg omadacycline (equivalent to 196 mg omadacycline tosylate) ( 3.2 )

3.1NUZYRA for Injection Each single-dose vial contains 100 mg omadacycline (equivalent to 131 mg omadacycline tosylate) which must be reconstituted and further diluted prior to intravenous infusion. The lyophilized powder is a yellow to dark orange cake.

3.2NUZYRA Tablets Each tablet contains 150 mg of omadacycline (equivalent to 196 mg omadacycline tosylate) in yellow, diamond-shaped, film-coated tablets debossed with OMC on one side and 150 on the other side.

⛔ Contraindications 50 words ▾

4 CONTRAINDICATIONS NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients [see Warnings andPrecautions (5.3) and Adverse Reactions (6.1) ]. Known hypersensitivity to omadacycline, tetracycline class antibacterial drugs or any of the excipients in NUZYRA ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Tooth Discoloration and Enamel Hypoplasia : The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. ( 5.1 , 8.1 , 8.4 ) Inhibition of Bone Growth: The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. ( 5.2 , 8.1 , 8.4 ) Clostridioides difficile -Associated Diarrhea : Evaluate if diarrhea occurs.

( 5.4 )

5.1Tooth Discoloration and Enamel Hypoplasia The use of NUZYRA during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the tetracycline class drugs, but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported with tetracycline class drugs.

Advise the patient of the potential risk to the fetus if NUZYRA is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1 , 8.4) ].

5.2Inhibition of Bone Growth The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours.

This reaction was shown to be reversible when the drug was discontinued. Advise the patient of the potential risk to the fetus if NUZYRA is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1 , 8.4) ] .

5.3Hypersensitivity Reactions Hypersensitivity reactions have been reported with NUZYRA [see Adverse Reactions (6.1) ]. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline class antibacterial drugs. NUZYRA is structurally similar to other tetracycline class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline class antibacterial drugs [see Contraindications (4) ] .

Discontinue NUZYRA if an allergic reaction occurs.

5.4Clostridioides difficile- Associated Diarrhea Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

5.5Tetracycline Class Effects NUZYRA is structurally similar to tetracycline class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, fixed drug eruption, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline class antibacterial drugs, and may occu… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section of labeling: Tooth Development and Enamel Hypoplasia [see Warnings and Precautions (5.1) ] Inhibition of Bone Growth [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Tetracycline Class Effects [see Warnings and Precautions ( 5.5 )] ABSSSI: The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, headache and diarrhea.

CABP : The most common adverse reactions (incidence ≥2%) are alanine aminotransferase increased, headache, hypertension, and aspartate aminotransferase increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials 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. Overview of the Safety Evaluation of NUZYRA NUZYRA was evaluated in three Phase 3 pivotal clinical trials (Trial 1, Trial 2 and Trial 3) and one Phase 3 postmarketing clinical trial (Trial 4). These trials included one pivotal Phase 3 trial in CABP patients (Trial 1), one Phase 3 postmarketing trial in CABP patients (Trial 4), and two pivotal Phase 3 trials in ABSSSI patients (Trial 2 and Trial 3).

Across all Phase 3 trials, a total of 1409 patients were treated with NUZYRA. In Trials 2 and 3, 691 patients with ABSSSI received NUZYRA, of which 368 patients were treated with only oral NUZYRA. In Trials 1 and 4, 718 patients with CABP were treated with NUZYRA.

Clinical Trial Experience in Patients with Community-Acquired Bacterial Pneumonia Trial 1 was a Phase 3 CABP trial that enrolled 774 adult patients, 386 randomized to NUZYRA (382 received at least one dose of NUZYRA and 4 patients did not receive the study drug) and 388 randomized to moxifloxacin (all 388 received at least one dose of moxifloxacin). The mean age of patients treated with NUZYRA was 61 years (range 19 to 97 years) and 42% were greater than or equal to 65 years of age. Overall, patients treated with NUZYRA were predominantly male (53.7%), white (92.4%), and had a mean body mass index (BMI) of 27.3 kg/m 2 .

Approximately 47% of NUZYRA treated patients had CrCl <90 ml/min. Patients were administered an IV to oral switch dosage regimen of NUZYRA. The total treatment duration was 7 to 14 days.

Mean duration of IV treatment was 5.7 days and mean total duration of treatment was 9.6 days in both treatment arms. Trial 4 was a Phase 3 CABP trial that enrolled 670 adult patients, 336 randomized to NUZYRA (all 336 received at least one dose of NUZYRA) and 334 randomized to moxifloxacin (332 received at least one dose of moxifloxacin and 2 patients did not receive the study drug). The mean age of patients treated with NUZYRA was 63.3 years (range 23 to 96 years) and 47.6% were greater than or equal to 65 years of age.

Overall, patients treated with NUZYRA were predominantly male (53.0%), white (99.7%), and had a mean body mass index (BMI) of 27.0 kg/m 2 . Approximately 54% of NUZYRA treated patients had CrCl <90 ml/min. Patients were administered an IV to oral switch dosage regimen of NUZYRA.

The total treatment duration was 7 to 10 days with up to 14 days allowed for patients with positive blood cultures at the Screening visit. Mean duration of IV treatment was 6.6 days and mean total duration of treatment was 9.0 days in both treatment arms. Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In Trial 1, a total of 23/382 (6.0%) patients treated with NUZYRA and 26/388 (6.7%) patients treated with moxifloxacin experienced ser… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 111 words ▾

7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. ( 7.1 ) Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. ( 2.1 , 7.2 )

7.1Anticoagulant Drugs Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while also taking NUZYRA.

7.2Antacids and Iron Preparations Absorption of oral tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron containing preparations [see Dosage and Administration (2.1) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Breastfeeding is not recommended during treatment with NUZYRA. ( 8.2 )

8.1Pregnancy Risk Summary NUZYRA, like other tetracycline class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy [see Warnings and Precautions ( 5.1 , 5.2) , Data, Use in Specific Populations ( 8.4 )]. The limited available data of NUZYRA use in pregnant women is insufficient to inform drug associated risk of major birth defects and miscarriages. Animal studies indicate that administration of omadacycline during the period of organogenesis resulted in fetal loss and/or congenital malformations in pregnant rats and rabbits at 7 times and 3 times the mean AUC exposure, respectively, of the clinical intravenous dose of 100 mg and the oral dose of 300 mg.

Reductions in fetal weight occurred in rats at all administered doses (see Data ). In a fertility study, administration to rats during mating and early pregnancy resulted in embryo loss at 20 mg/kg/day; systemic exposure based on AUC was approximately equal to the clinical exposure level [see Nonclinical Toxicology ( 13.1) ] . Results of studies in rats with omadacycline have shown tooth discoloration.

The estimated 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 15-20%.

Data Animal Data Intravenous infusion of omadacycline to pregnant rats during organogenesis (gestation days 6-17) at doses of 5 to 80 mg/kg/day resulted in maternal lethality at 80 mg/kg/day. Increased embryo-fetal lethality and fetal malformations (whole body edema) occurred at 60 mg/kg/day (7 times the clinical AUC), dose-dependent reductions in fetal body weight occurred at all doses, and delayed skeletal ossification occurred at doses as low as 10 mg/kg/day (Systemic exposure based on AUC at a similar dose in unmated female rats in a separate study was approximately half the clinical exposure).

In pregnant rabbits, intravenous infusion of 5, 10 or 20 mg/kg/day during organogenesis (gestation days 7-18) resulted in maternal lethality and body weight loss at 20 mg/kg/day. Embryo-fetal lethality, congenital malformations of the skeleton, and reduced fetal weight also occurred at 20 mg/kg/day (7 times the clinical AUC). Cardiac and lung malformations were present in dose-related incidence at 10 and 20 mg/kg/day.

The fetal no-adverse-effect-level in the rabbit embryo-fetal development study was 5 mg/kg/day, at approximately 1.2 times the clinical steady state AUC. Intravenous infusion of omadacycline to pregnant and lactating rats at doses of 7.5, 15 and 30 mg/kg/day did not adversely affect survival, growth (other than lower pup body weights and/or gains at the high dose that were only statistically significant at sporadic intervals), postnatal development, behavior, or reproductive capability of offspring at maternal doses up to 30 mg/kg/day (approximately equivalent to 3 times the IV clinical dose of 100 mg/day, based on doses normalized for total body surface area), the highest dose tested, although dosing was discontinued early in a number of animals in this group due to injection site intolerance.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity also has been noted in animals treated early in pregnancy.

8.2Lactation Risk Summary There is no information on the presence of omadacycline in human milk, the effects on the breastfed infant or the effects on milk production. Tetracyclines are excreted in human m… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary NUZYRA, like other tetracycline class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy [see Warnings and Precautions ( 5.1 , 5.2) , Data, Use in Specific Populations ( 8.4 )]. The limited available data of NUZYRA use in pregnant women is insufficient to inform drug associated risk of major birth defects and miscarriages. Animal studies indicate that administration of omadacycline during the period of organogenesis resulted in fetal loss and/or congenital malformations in pregnant rats and rabbits at 7 times and 3 times the mean AUC exposure, respectively, of the clinical intravenous dose of 100 mg and the oral dose of 300 mg.

Reductions in fetal weight occurred in rats at all administered doses (see Data ). In a fertility study, administration to rats during mating and early pregnancy resulted in embryo loss at 20 mg/kg/day; systemic exposure based on AUC was approximately equal to the clinical exposure level [see Nonclinical Toxicology ( 13.1) ] . Results of studies in rats with omadacycline have shown tooth discoloration.

The estimated 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 15-20%.

Data Animal Data Intravenous infusion of omadacycline to pregnant rats during organogenesis (gestation days 6-17) at doses of 5 to 80 mg/kg/day resulted in maternal lethality at 80 mg/kg/day. Increased embryo-fetal lethality and fetal malformations (whole body edema) occurred at 60 mg/kg/day (7 times the clinical AUC), dose-dependent reductions in fetal body weight occurred at all doses, and delayed skeletal ossification occurred at doses as low as 10 mg/kg/day (Systemic exposure based on AUC at a similar dose in unmated female rats in a separate study was approximately half the clinical exposure).

In pregnant rabbits, intravenous infusion of 5, 10 or 20 mg/kg/day during organogenesis (gestation days 7-18) resulted in maternal lethality and body weight loss at 20 mg/kg/day. Embryo-fetal lethality, congenital malformations of the skeleton, and reduced fetal weight also occurred at 20 mg/kg/day (7 times the clinical AUC). Cardiac and lung malformations were present in dose-related incidence at 10 and 20 mg/kg/day.

The fetal no-adverse-effect-level in the rabbit embryo-fetal development study was 5 mg/kg/day, at approximately 1.2 times the clinical steady state AUC. Intravenous infusion of omadacycline to pregnant and lactating rats at doses of 7.5, 15 and 30 mg/kg/day did not adversely affect survival, growth (other than lower pup body weights and/or gains at the high dose that were only statistically significant at sporadic intervals), postnatal development, behavior, or reproductive capability of offspring at maternal doses up to 30 mg/kg/day (approximately equivalent to 3 times the IV clinical dose of 100 mg/day, based on doses normalized for total body surface area), the highest dose tested, although dosing was discontinued early in a number of animals in this group due to injection site intolerance.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity also has been noted in animals treated early in pregnancy.

🧒 Pediatric Use 63 words ▾

8.4Pediatric Use Safety and effectiveness of NUZYRA in pediatric patients below the age of 18 years have not been established. Due to the adverse effects of the tetracycline class of drugs, including NUZYRA on tooth development and bone growth, use of NUZYRA in pediatric patients less than 8 years of age is not recommended [see Warnings and Precautions (5.1 , 5.2) ].

🧓 Geriatric Use 137 words ▾

8.5Geriatric Use Of the total number of patients who received NUZYRA for ABSSSI in clinical trials 2 and 3 (n=691), 57 (8.2%) patients were ≥65 years of age, including 20 (2.9%) patients who were ≥75 years of age. Of the total number of patients who received NUZYRA for CABP in clinical trials 1 and 4 (n=718), 330 (46%) patients were ≥65 years of age, including 156 (21.7%) patients who were ≥75 years of age [see Clinical Studies (14)] . No overall differences in safety or effectiveness were observed between these patients and younger adult patients.

However, greater sensitivity of some older individuals cannot be ruled out. No significant difference in NUZYRA exposure was observed between healthy elderly subjects and younger subjects following a single 100 mg IV dose of NUZYRA [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 32 words ▾

10 OVERDOSAGE No specific information is available on the treatment of overdosage with NUZYRA. Following a 100 mg single dose intravenous administration of omadacycline, 8.9% of dose is recovered in the dialysate.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action NUZYRA is an antibacterial drug [see Microbiology (12.4) ].

12.2Pharmacodynamics Cardiac Electrophysiology Based on the nonclinical and clinical data, including electrocardiogram evaluation in the phase 3 clinical trials, one of which had moxifloxacin as a control group, no clinically relevant QTc prolongation was observed at the maximum recommended dose of omadacycline. Cardiac Physiology-Increase in Heart Rate In phase 1 studies conducted in healthy volunteers, reversible dose-dependent increases in heart rate have been observed following administration of single and multiple doses of omadacycline.

The clinical implication of this finding is unknown [see Adverse Reactions (6.1) ]. In a standard radiolabeled ligand binding assays, omadacycline was shown to inhibit binding of H-scopolamine to the M2 subtype of the muscarinic acetylcholine receptor. In the heart, muscarinic M2 receptors serve as mediators of the parasympathetic input that normally is received via the vagus nerve and stimulation of the receptor increases membrane potassium conductance through the acetylcholine-dependent channel, which slows depolarization and reduces pacemaker activity in the sinoatrial node.

12.3Pharmacokinetics The pharmacokinetic parameters of NUZYRA after single and multiple oral and intravenous doses are summarized in Table 6 . Table 6: Mean (SD) Pharmacokinetic Parameters of NUZYRA in Healthy Adult Subjects Dose and Route of Administration 100 mg IV 300 mg Oral 450 mg Oral C max = maximum plasma concentration, AUC = area under concentration-time curve, IV = intravenous, ND = not determined, T max = time to C max PK Parameters All PK parameters presented as mean (standard deviation), Number of Subjects, unless otherwise specified C max ng/mL Single dose 1507 (582) (n=63) 548 (146) (n=103) 874 (232) (n=24) Steady state 2116 (680) (n=41) 952 (420) (n=43) 1077 (269) (n=24) AUC h*ng/mL Single dose Presented as AUC (0-inf) 9358 (2072) (n=62) 9399 (2559) (n=102) 13504 (3634) (n=24) Steady state Presented as AUC (0-24) 12140 (3223) (n=41) 11156 (5010) (n=43) 13367 (3469) (n=24) Accumulation Accumulation ratio

1.5Absorption Bioavailability 34.5% following single 300 mg dose of NUZYRA T max Median (min, max) Single dose 0.6 (0.3, 0.7) (n=63) 2.5 (1, 4.1) (n=103) 2.5 (1.5, 3) (n=24) Steady state 0.5 (0, 1) (n=41) 2.5 (0, 8) (n=43) 2.5 (1.5, 4) (n=24) Distribution Plasma Protein Binding 20%; not concentration dependent Volume of Distribution L Single dose 256 (66) (n=62) 794 Presented as apparent clearance or volume of distribution (188) (n=27) 914 (821.9) (n=23) Steady state 190 (53) (n=41) 440 (262) (n=34) 607 (197.4) (n=24) Elimination Elimination Half-Life h Single dose 16.4 (2.1) (n=62) 15.0 (2.5) (n=81) 13.45 (1.7) (n=23) Steady state 16.0 (3.5) (n=41) 15.5 (1.7) (n=21) 16.83 (1.4) (n=23) Systemic Clearance L/h Single dose 11.24 (2.7) (n=62) 34.6 (10.7) (n=27) 43.4 (49.8) (n=23) Steady state 8.8 (2.2) (n=41) 18.3 (8.3) (n=34) 21.2 (8.9) (n=24) Renal Clearance L/h 3.1 (0.69) (n=8) Metabolism Omadacycline is not metabolized Excretion (% dose) Urine 27 (3.5) (n=8)

14.4Following administration of radiolabeled omadacycline (2.3) (n=6) ND Feces ND 81.1 (2.3) (n=6) ND Absorption The exposure to omadacycline is similar between a 300 mg oral dose and a 100 mg intravenous dose of NUZYRA in healthy fasted subjects. Effect of Food Ingestion of a standard high-fat nondairy meal (855 calories; 59% calories from fat) and standard high-fat meal including dairy (985 calories; 60% calories from fat) 2-hours before administration of a single 300 mg oral dose of NUZYRA decreased the rate (Cmax) and extent of absorption (AUC) by 40% and 42%, and 59% and 63%, respectively compared to administration of NUZYRA under fasting conditions.

The rate and extent of absorption of NUZYRA were not substantially decreased when a high-fat nondairy meal (800-1000 calories; 50% calories from fat) was ingested 4 hours pre-dose. Fo… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 13 words ▾

12.1Mechanism of Action NUZYRA is an antibacterial drug [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling 157 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied NUZYRA for Injection NUZYRA for Injection is supplied as a sterile lyophilized powder in a single-dose colorless glass vial, with each vial containing 100 mg of NUZYRA (equivalent to 131 mg omadacycline tosylate). They are supplied as follows: 100 mg single-dose vial (NDC 71715-001-02), packaged in cartons of 10. NUZYRA Tablets NUZYRA Tablets contains 150 mg of omadacycline (equivalent to 196 mg omadacycline tosylate) in yellow, diamond-shaped, film-coated tablets debossed with OMC on one side and 150 on the other side.

They are supplied as follows: Blister package of 6 (NDC 71715-002-21) Blister package of 30 (5 blister cards of 6 tablets each) (NDC 71715-002-27)

16.2Storage and Handling NUZYRA for Injection and NUZYRA Tablets should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] [see Dosage and Administration ( 2.5) ]. Do not freeze.

📦 Storage and Handling 44 words ▾

16.2Storage and Handling NUZYRA for Injection and NUZYRA Tablets should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] [see Dosage and Administration ( 2.5) ]. Do not freeze.

📋 Description 167 words ▾

11 DESCRIPTION NUZYRA contains omadacycline tosylate, an aminomethylcycline which is a semisynthetic derivative of the tetracycline class of antibacterial drugs, for intravenous or oral administration. The chemical name of omadacycline tosylate is (4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-9-(2,2-dimethylpropylaminomethyl)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide, 4-methylbenzenesulfonate. The molecular formula is C 36 H 48 N 4 O 10 S (monotosylate salt) and the molecular weight is 728.9 (monotosylate salt).

The following represents the chemical structure of omadacycline tosylate: NUZYRA (omadacycline) for injection is a yellow to dark orange sterile lyophilized powder. Each vial of NUZYRA for injection contains 100 mg of omadacycline (equivalent to 131 mg omadacycline tosylate). Inactive ingredients: Sucrose (100 mg); may include hydrochloric acid and/or sodium hydroxide for pH adjustment.

NUZYRA (omadacycline) tablets for oral administration are yellow film coated tablets containing 150 mg of omadacycline (equivalent to 196 mg omadacycline tosylate), and the following inactive ingredients: Colloidal silicon dioxide, crospovidone, glycerol monocaprylocaprate, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyvinyl alcohol, sodium bisulfite, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Nausea and Vomiting Advise patients that nausea and vomiting can be an adverse reaction to NUZYRA. Advise patients that a greater proportion of patients who received the oral loading dose of NUZYRA for treatment of ABSSSI experienced nausea and vomiting. Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious allergic reactions require immediate treatment.

Ask the patient about any previous hypersensitivity reactions to NUZYRA, or other tetracycline class antibacterials [see Warnings and Precautions (5.3) ] . Administration with Food Instruct patients to fast 4 hours before and 2 hours after taking NUZYRA tablets and not to consume dairy products, antacids, or multivitamins for 4 hours after taking NUZYRA tablets [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) ] . Tooth Discoloration and Inhibition of Bone Growth Advise patients that NUZYRA, like other tetracycline class drugs, may cause permanent tooth discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy.

Tell your healthcare provider right away if you become pregnant during treatment [see Warnings and Precautions (5.1 , 5.2) and Use in Specific Populations (8.1 , 8.4) ]. Lactation Advise women not to breastfeed during treatment with NUZYRA and for 4 days after the last dose [see Use in Specific Populations (8.2) ]. Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs, including NUZYRA, which usually ends when the antibacterial drugs is discontinued.

Sometimes after starting treatment with antibacterial drugs, patients can develop watery or bloody stools (with or without stomach cramps and fever). If this occurs, patients should contact their physician as soon as possible. Tetracycline Class Adverse Reactions Inform patients that NUZYRA is similar to tetracycline class antibacterial drugs and may have similar adverse reactions [see Warnings and Precautions (5.5) ] .

Antibacterial Resistance Patients should be counseled that antibacterial drugs including NUZYRA should only be used to treat bacterial infections. They do not treat viral infections ( e.g. , the common cold). When NUZYRA is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by NUZYRA or other antibacterial drugs in the future.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetic parameters of NUZYRA after single and multiple oral and intravenous doses are summarized in Table 6 . Table 6: Mean (SD) Pharmacokinetic Parameters of NUZYRA in Healthy Adult Subjects Dose and Route of Administration 100 mg IV 300 mg Oral 450 mg Oral C max = maximum plasma concentration, AUC = area under concentration-time curve, IV = intravenous, ND = not determined, T max = time to C max PK Parameters All PK parameters presented as mean (standard deviation), Number of Subjects, unless otherwise specified C max ng/mL Single dose 1507 (582) (n=63) 548 (146) (n=103) 874 (232) (n=24) Steady state 2116 (680) (n=41) 952 (420) (n=43) 1077 (269) (n=24) AUC h*ng/mL Single dose Presented as AUC (0-inf) 9358 (2072) (n=62) 9399 (2559) (n=102) 13504 (3634) (n=24) Steady state Presented as AUC (0-24) 12140 (3223) (n=41) 11156 (5010) (n=43) 13367 (3469) (n=24) Accumulation Accumulation ratio

1.5Absorption Bioavailability 34.5% following single 300 mg dose of NUZYRA T max Median (min, max) Single dose 0.6 (0.3, 0.7) (n=63) 2.5 (1, 4.1) (n=103) 2.5 (1.5, 3) (n=24) Steady state 0.5 (0, 1) (n=41) 2.5 (0, 8) (n=43) 2.5 (1.5, 4) (n=24) Distribution Plasma Protein Binding 20%; not concentration dependent Volume of Distribution L Single dose 256 (66) (n=62) 794 Presented as apparent clearance or volume of distribution (188) (n=27) 914 (821.9) (n=23) Steady state 190 (53) (n=41) 440 (262) (n=34) 607 (197.4) (n=24) Elimination Elimination Half-Life h Single dose 16.4 (2.1) (n=62) 15.0 (2.5) (n=81) 13.45 (1.7) (n=23) Steady state 16.0 (3.5) (n=41) 15.5 (1.7) (n=21) 16.83 (1.4) (n=23) Systemic Clearance L/h Single dose 11.24 (2.7) (n=62) 34.6 (10.7) (n=27) 43.4 (49.8) (n=23) Steady state 8.8 (2.2) (n=41) 18.3 (8.3) (n=34) 21.2 (8.9) (n=24) Renal Clearance L/h 3.1 (0.69) (n=8) Metabolism Omadacycline is not metabolized Excretion (% dose) Urine 27 (3.5) (n=8)

14.4Following administration of radiolabeled omadacycline (2.3) (n=6) ND Feces ND 81.1 (2.3) (n=6) ND Absorption The exposure to omadacycline is similar between a 300 mg oral dose and a 100 mg intravenous dose of NUZYRA in healthy fasted subjects. Effect of Food Ingestion of a standard high-fat nondairy meal (855 calories; 59% calories from fat) and standard high-fat meal including dairy (985 calories; 60% calories from fat) 2-hours before administration of a single 300 mg oral dose of NUZYRA decreased the rate (Cmax) and extent of absorption (AUC) by 40% and 42%, and 59% and 63%, respectively compared to administration of NUZYRA under fasting conditions.

The rate and extent of absorption of NUZYRA were not substantially decreased when a high-fat nondairy meal (800-1000 calories; 50% calories from fat) was ingested 4 hours pre-dose. Following ingestion of either a light non-fat (300-350 calories; ≤5% calories from fat), or a standard low-fat (800-1000 calories; 30% calories from fat), or a standard high fat (800-1000 calories; 50% calories from fat) meal 2 hours post-dose, the AUC and C max were not substantially altered, as compared to fasting conditions. Distribution Plasma protein binding of omadacycline is approximately 20% and is not concentration dependent.

The mean (% CV) volume of distribution of omadacycline at steady-state following IV administration of NUZYRA in healthy subjects was 190 (27.7) L. Elimination Renal clearance of omadacycline following IV administration of NUZYRA ranged from 2.4 to

3.3L/h in healthy subjects. Metabolism In vitro studies using human liver microsomes and hepatocytes demonstrated that omadacycline is not metabolized. Excretion Following a 100 mg IV dose of NUZYRA, 27% of the dose was recovered as unchanged omadacycline in the urine.

In healthy male volunteers receiving 300 mg oral [ 14 C] NUZYRA, 77.5% to 84.0% of the dose was recovered in the feces, approximately 14.4% (range 10.8% to 17.4%) in the urine, with 95.5% of the administered radioactive dose recovered after 7 days. Lung Penetration The mean omadacycline… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 156 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology Based on the nonclinical and clinical data, including electrocardiogram evaluation in the phase 3 clinical trials, one of which had moxifloxacin as a control group, no clinically relevant QTc prolongation was observed at the maximum recommended dose of omadacycline. Cardiac Physiology-Increase in Heart Rate In phase 1 studies conducted in healthy volunteers, reversible dose-dependent increases in heart rate have been observed following administration of single and multiple doses of omadacycline.

The clinical implication of this finding is unknown [see Adverse Reactions (6.1) ]. In a standard radiolabeled ligand binding assays, omadacycline was shown to inhibit binding of H-scopolamine to the M2 subtype of the muscarinic acetylcholine receptor. In the heart, muscarinic M2 receptors serve as mediators of the parasympathetic input that normally is received via the vagus nerve and stimulation of the receptor increases membrane potassium conductance through the acetylcholine-dependent channel, which slows depolarization and reduces pacemaker activity in the sinoatrial node.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Community-Acquired Bacterial Pneumonia A total of 1444 adults with CABP were randomized in two multinational, double-blind, double-dummy trials (Trial 1 NCT02531438 and Trial 4 NCT04779242) comparing NUZYRA to moxifloxacin. NUZYRA was administered 100 mg intravenously every 12 hours for two doses on Day 1, followed by 100 mg intravenously daily, or 300 mg orally, daily. Moxifloxacin 400 mg was administered intravenously or orally daily.

Total treatment duration was 7-14 days. All enrolled patients were expected to require a minimum of at least 3 days of intravenous treatment. Efficacy and safety of an oral loading dose was not evaluated in CABP.

In Trial 1, a total of 386 patients were randomized to NUZYRA and 388 patients were randomized to moxifloxacin. Patient demographic and baseline characteristics were balanced between the treatment groups. Patients were predominantly male (55%) and white (92%).

Approximately 60% of patients in each group belonged to PORT Risk Class III, 26% were PORT Risk Class IV and 14.5% were PORT Risk Class II. The median age was 62 years, mean BMI was 27.34 kg/m2, and approximately 47% of NUZYRA treated patients had CrCl <90 ml/min. Among NUZYRA-treated patients, common comorbid conditions included hypertension (49.5%), diabetes mellitus (16.3%), chronic lung disease (21.2%), atrial fibrillation (10.1%), and coronary artery disease (9.1%).

The majority of sites were in Eastern Europe, which accounted for 82% of enrollment; 3 patients were enrolled in the US. In Trial 4, a total of 336 patients were randomized to NUZYRA and 334 patients were randomized to moxifloxacin. Patient demographic and baseline characteristics were balanced between the treatment groups.

Patients were predominantly male (51.6%) and white (99.7%). Approximately 76% of patients belonged to PORT Risk Class III, and 24% were PORT Risk Class IV. The median age was 65.0 years, mean BMI was 27.0 kg/m2, and approximately 56% of NUZYRA treated patients had CrCl <90 ml/min.

Among NUZYRA-treated patients, common comorbid conditions included hypertension (49.4%), diabetes mellitus (19.6%), chronic lung disease (11.9%), atrial fibrillation (6.5%), and coronary artery disease (1.2%). All sites were in Eastern Europe. Clinical success at the early clinical response (ECR) timepoint, 72 to 120 hours after the first dose, was defined as survival with improvement in at least two of four symptoms (cough, sputum production, chest pain, dyspnea) without deterioration in any of these four symptoms in the intent to treat population (ITT), which consisted of all randomized patients.

Table 7 presents the clinical success rates at the ECR timepoint (ITT population). Table 7: Clinical Success at the ECR Timepoint in Trial 1 and Trial 4 (ITT Population) Study NUZYRA n/N (%) Moxifloxacin n/N (%) Treatment Difference (95% CI 95% confidence interval for the treatment difference ) Trial 2 301/336 (89.6) 293/334 (87.7) +1.9 (-3.0, 6.8) * Clinical Success at the early clinical response (ECR) timepoint, 72 to 120 hours after the first dose, was defined as survival with improvement in at least two of four symptoms (cough, sputum production, chest pain, dyspnea) from baseline without deterioration in any of these symptoms, with no receipt of antibacterial treatment either as a rescue for CABP or as a treatment for other infections that may be effective for CABP, and no discontinuation of study treatment due to AE.

Trial 1 313/386 (81.1) 321/388 (82.7) -1.6 (-7.1, 3.8) Clinical response was also assessed by the investigator at the post therapy evaluation visit (PTE), 5 to 10 days after last dose of study drug and defined as survival and improvement in signs and symptoms of CABP, based on the clinician's judgment, to the extent that further antibacterial therapy is not necessary. Table 8 presents the results of clinical response at the PTE visit for both the ITT population and the Clinically Evaluable (CE) population, which consisted of all… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies with omadacycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with the related antibacterial drugs, oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors). In a 9-month chronic toxicity study in monkeys, there were no observations of hyperplasia or neoplasia at doses up to 300 mg/kg/day (4-times the clinical AUC exposure).

Mutagenesis Omadacycline was positive for clastogenicity and aneugenicity in an in vitro chromosome aberration assay in Chinese hamster ovary (CHO) cells and for mutagenicity in an in vitro forward mutation assay in mouse lymphoma cells. These effects were seen in the presence of metabolizing enzymes. Omadacycline was negative in a chromosomal aberration test in Chinese hamster V79 cells and in vivo micronucleus assays administered intraperitoneally to ICR mice or intravenously to HanRcc: WIST rats.

Impairment of Fertility Omadacycline administration to male rats in a fertility study caused reduced sperm counts and sperm motility at 20-mg/kg/day (approximately 1.3 times clinical systemic exposure, based on AUC in a separate study in rats at a similar dose), but had no effect on male fertility parameters. In general toxicity studies, inhibition of spermatogenesis occurred after administration of 45-mg/kg/day omadacycline (6 to 8 times the clinical AUC exposure) for 37 days or longer, but not at lower doses (15-mg/kg/day, ≤ 2 times clinical AUC exposure) or shorter treatment periods (4 weeks or less).

In female rats, fertility was reduced at the 20-mg/kg/day dose (approximately equivalent to human exposures in a separate study in unmated females), characterized by reduced ovulation and increased embryonic loss when treatment occurred from before mating through early pregnancy.

13.2Animal Toxicology and/or Pharmacology In a 9-month study, omadacycline at oral doses of 30 to 300 mg/kg/day in monkeys (approximately 1-to 4-times the clinical AUC exposure) resulted in hyperpigmentation of lymphoid, reproductive, endocrine, including thyroid, and duodenum tissues. Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by omadacycline, oxytetracycline, doxycycline, tetracycline PO4, and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4, and methacycline; in dogs by doxycycline and minocycline; in monkeys by omadacycline and minocycline.

Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies with omadacycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with the related antibacterial drugs, oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors). In a 9-month chronic toxicity study in monkeys, there were no observations of hyperplasia or neoplasia at doses up to 300 mg/kg/day (4-times the clinical AUC exposure).

Mutagenesis Omadacycline was positive for clastogenicity and aneugenicity in an in vitro chromosome aberration assay in Chinese hamster ovary (CHO) cells and for mutagenicity in an in vitro forward mutation assay in mouse lymphoma cells. These effects were seen in the presence of metabolizing enzymes. Omadacycline was negative in a chromosomal aberration test in Chinese hamster V79 cells and in vivo micronucleus assays administered intraperitoneally to ICR mice or intravenously to HanRcc: WIST rats.

Impairment of Fertility Omadacycline administration to male rats in a fertility study caused reduced sperm counts and sperm motility at 20-mg/kg/day (approximately 1.3 times clinical systemic exposure, based on AUC in a separate study in rats at a similar dose), but had no effect on male fertility parameters. In general toxicity studies, inhibition of spermatogenesis occurred after administration of 45-mg/kg/day omadacycline (6 to 8 times the clinical AUC exposure) for 37 days or longer, but not at lower doses (15-mg/kg/day, ≤ 2 times clinical AUC exposure) or shorter treatment periods (4 weeks or less).

In female rats, fertility was reduced at the 20-mg/kg/day dose (approximately equivalent to human exposures in a separate study in unmated females), characterized by reduced ovulation and increased embryonic loss when treatment occurred from before mating through early pregnancy.

📄 Recent Major Changes 16 words ▾

Warnings and Precautions, Mortality imbalance in Patients with Community-Acquired Bacterial Pneumonia ( 5.1 ) Removed 5/2026

📄 Package Label / Principal Display Panel 97 words ▾

PRINCIPAL DISPLAY PANEL - 6 Tablet Blister Pack Carton NDC 71715-002-21 RX ONLY once-daily NUZYRA ® (omadacycline) 150 mg tablets Contains 6 tablets Nuzyra-04

PRINCIPAL DISPLAY PANEL - 10 Vial Carton NDC 71715-001-02 Contains 10 of NDC 71715-001-01 RX ONLY NUZYRA ® (omadacycline) for injection 100 mg per single-dose vial. Must be reconstituted and further diluted. For intravenous infusion only. 100 mg Contains 10 vials Nuzyra-03

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton NDC 71715-002-27 RX ONLY once-daily NUZYRA ® (omadacycline) 150 mg tablets Contains 30 tablets (5 blister cards of 6 tablets each) Nuzyra-05

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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
1.3K
Units reimbursed last 4 qtrs
47.3K
Gross reimbursed last 4 qtrs
$12.64M
Avg / prescription
$9,817.40
Avg / unit
$267.12
Latest quarter Q4 2025
351Rx
Fee-for-service vs managed care ⓘ
55% FFS 45% MCO
Fee-for-service · 712 Rx Managed care · 576 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: no data reported WI Michigan: 536 units · 5.3 per 100k residents MI New York: 11,575 units · 59.1 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: 1,176 units · 9.4 per 100k residents IL Indiana: no data reported IN Ohio: 2,990 units · 25.4 per 100k residents OH Pennsylvania: 2,402 units · 18.5 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 10,213 units · 26.2 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: 2,188 units · 48.3 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 987 units · 27.3 per 100k residents CT Rhode Island: no data reported RI Arizona: 704 units · 9.5 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 1,370 units · 19.2 per 100k residents TN North Carolina: 2,384 units · 22.0 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 5,757 units · 126 per 100k residents LA Mississippi: no data reported MS Alabama: 1,750 units · 34.3 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 3,306 units · 14.6 per 100k residents FL
Units reimbursed · per 100k residents
5.3126
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 Louisiana 126 /100k
2 New York 59.1 /100k
3 Kentucky 48.3 /100k
4 Alabama 34.3 /100k
5 Connecticut 27.3 /100k
6 California 26.2 /100k
7 Ohio 25.4 /100k
8 North Carolina 22.0 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
6 tablets this page71715-0002-27 1,288 Rx · $12,644,806
6 tablets71715-0002-21 326 Rx · $2,841,943
Drug total (last 4 qtrs): 1,614 Rx · 58,220 units · $15,486,749 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Nuzyra — 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 Nuzyra. 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
$46.35M
Claims incl. refills
4K
Beneficiaries
2.4K
Spend / beneficiary
$19,505.93
Spend / claim
$11,630.13
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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Paratek Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 6 tablets (71715-0002-21). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Paratek Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71715-0001-02 · Paratek 71715-0003-31 · Paratek →
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.