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EMROSI Minocycline Hydrochloride Extended-Release 40 mg Capsule, 30-count — NDC 69489-0131-30 package photo

EMROSI Minocycline Hydrochloride Extended-Release 40 mg Capsule, 30-count

by Journey Medical Corporation · 30 CAPSULE in 1 BOTTLE (69489-131-30)
NDC 69489-0131-30
🏷️ FDA NDC (as labeled) 69489-131-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $44.97/unit — full pricing hub ↓
Also comes in: 7 capsules 69489-0131-07
Rx only Brand On market Non-controlled
🗂️ 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) 69489-131-30
Product NDC 69489-131
11-digit billing NDC 69489013130
NCPDP billing unit EA — each (per item)
RxCUI 2706371, 2706378
UNII 0020414E5U
UPC 0369489131071
Application # NDA219015
SPL Set ID 0899eb25-8807-037c-f66c-141a2696b1c0
Established class (EPC) Tetracycline-class Drug
Physiologic effect Decreased Prothrombin Activity
Chemical class Tetracyclines
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-01
Route ORAL
Dosage form CAPSULE
Substance MINOCYCLINE HYDROCHLORIDE
GCN Seq No 086729
GCN 56483
HICL code 004015
Ingredient (HICL) Minocycline Hcl
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 08:12.24.00
AHFS class Tetracycline Antibiotics
FDB label name EMROSI ER 40 MG CAPSULE
FDB brand name Emrosi
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 69489-131-30 — 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 → 69489-0131-30. 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 Drug class.

Pharmacologic class Tetracycline-class Drug
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antiinfectives for treatment of acne, 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.

🏭 Manufacturer & labeler

LabelerJourney Medical Corporation
Application holderJOURNEY MEDICAL CORP
FDA applicationNDA219015 (NDA)
Labeler code69489
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio8 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 EMROSI ER 40 MG CAPSULE Ingredient Minocycline Hcl
📗 Our plain-language guide HelloPharmacist
  • Good news — standard minocycline oral capsules and tablets can be taken with or without food, so you have flexibility there. The most important thing is to take it with a full glas...
  • Can I take my minocycline capsule or tablet with food, or does it have to be on an empty stomach?
  • The extended-release tablets for acne are typically taken once daily for 12 weeks. As with most acne treatments, you likely won't see dramatic results overnight — it takes time for...
  • I've been prescribed the extended-release minocycline tablets for acne. How long does it take to work, and how long do I take it?
📖 Read our full Minocycline guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 brown
ShapeCapsule
ImprintMEC;MEC
Size16 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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

13 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $44.97 $1,349.16 / 30 capsules
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
Emrosi 40 mgthis 69489-0131-30 Journey 30 capsules — — 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

🏛️
2024
First FDA approval
Nov 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2039
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 Jan 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 1, 2024 RLD RS ⏳ ~12.3 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 11364212 — method of use (U-4043)
US 11191740 — method of use (U-4043)
US 10905664 — method of use (U-4043)
US 12594252 — method of use (U-4043)
Exclusivity NP
2024 2026 2028 2030 2032 2034 2036 2038
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 (4)
PatentTypeUse codeExpires
US 11364212 ↗ Method of use U-4043 Jan 7, 2039
US 11191740 ↗ Method of use U-4043 Jan 7, 2039
US 10905664 ↗ Method of use U-4043 Jan 7, 2039
US 12594252 ↗ Method of use U-4043 Jan 7, 2039
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductNov 1, 2027
Common questions
Is there a generic version of EMROSI ER 40 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for EMROSI ER 40 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2039 — 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.

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

Medicare Part D (outpatient prescription) spending for Emrosi — 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 Emrosi. 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
$289.7K
Claims incl. refills
215
Beneficiaries
141
Spend / beneficiary
$2,054.86
Spend / claim
$1,347.61
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.

🔬 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 EMROSI (this brand).

Top reported reactions

Dizziness4
Rash4
Gastrointestinal Disorder2
Headache2
Pruritus2
Anaemia1
Arthralgia1

Age at onset

Adult3
Elderly3

Reporter sex

16 reports

Serious outcomes

Disabling1
Reports over time (by year) — tap or hover for the count & year
2025 2026 8 0
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
69489-0131-07 7 CAPSULE in 1 BOTTLE (69489-131-07) 2025-03-10 Active
69489-0131-30 You're viewing this 30 CAPSULE in 1 BOTTLE (69489-131-30) 2025-03-01 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 69489-0131-30?
NDC 69489-0131-30 is a 30-count package — 30 capsule in 1 bottle.
What is the difference between NDC 69489-0131-30 and NDC 69489-0131-07?
Both are EMROSI Minocycline Hydrochloride Extended-Release 40 mg Capsule — the drug itself is identical. NDC 69489-0131-30 is the 30-count package, while NDC 69489-0131-07 is the 7 capsules package.
What NDC number is used to bill for this package of EMROSI Minocycline Hydrochloride Extended-Release 40 mg Capsule?
Bill NDC 69489-0131-30 — the 11-digit billing format is 69489013130. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 FDA registers it as 69489-131-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69489-0131-30, written without dashes as 69489013130. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69489-0131-30, the first segment (69489) is the labeler code FDA assigned to Journey Medical Corporation; the middle segment (0131) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Journey Medical Corporation. 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 7 capsules (69489-0131-07). 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?
Journey Medical Corporation 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.

📄 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.
🎯 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 📋 Description 💬 Information for Patients
🎯 Indications and Usage 121 words ▾

1 INDICATIONS AND USAGE EMROSI is indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults. Limitations of Use This formulation of minocycline has not been evaluated in the treatment or prevention of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use EMROSI only as indicated.

EMROSI is a tetracycline-class drug indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment or prevention of infections. To reduce the development of drug-resistant bacteria and to maintain the effectiveness of other antibacterial drugs, use EMROSI only as indicated.

( 1 )

⏱️ Dosage and Administration 88 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of EMROSI is one capsule taken orally, once daily. Higher doses have not shown to be of additional benefit in the treatment of rosacea. EMROSI may be taken with or without food [see Clinical Pharmacology (12.3) ] .

Ingestion of food along with EMROSI may help to reduce the risk of esophageal irritation and ulceration. Swallow the capsule whole. Do not crush or chew the extended-release capsule.

The recommended dosage of EMROSI is 40 mg orally, once daily. ( 2 )

💊 Dosage Forms and Strengths 16 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release capsules: 40 mg. Extended-release capsules: 40 mg. ( 3 )

⛔ Contraindications 33 words ▾

4 CONTRAINDICATIONS EMROSI is contraindicated in patients with a history of hypersensitivity to any of the tetracyclines [see Warnings and Precautions (5.1) ]. Known hypersensitivity to any of the tetracyclines. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serious Skin/Hypersensitivity Reactions: Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. Discontinue EMROSI immediately if symptoms occur. ( 5.1 ) Tooth Discoloration and Enamel Hypoplasia: The use of EMROSI during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).

( 5.2 ) Inhibition of Bone Growth: Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. ( 5.3 ) Clostridioides difficile -Associated Diarrhea (Antibiotic-Associated Colitis): Discontinue if Clostridioides difficile -associated diarrhea (antibiotic-associated colitis) occurs. ( 5.4 ) Hepatotoxicity: Discontinue EMROSI if liver injury is suspected.

( 5.5 ) Central Nervous System Effects: May cause central nervous system side effects including light-headedness, dizziness, or vertigo. ( 5.6 ) Idiopathic Intracranial Hypertension: May cause idiopathic intracranial hypertension in adults and adolescents. Discontinue EMROSI if symptoms occur.

( 5.7 ) Autoimmune Syndromes: Minocycline has been associated with autoimmune syndromes; discontinue EMROSI immediately if symptoms occur. ( 5.8 ) Metabolic Effects: If renal impairment exists, monitor serum levels of EMROSI during treatment, discontinue EMROSI if necessary. ( 5.9 )

5.1Hypersensitivity Reaction and Serious Skin Reactions Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis.

Fever and lymphadenopathy may be present. In some cases, death has been reported. If this syndrome is recognized, discontinue EMROSI immediately.

5.2Tooth Discoloration and Enamel Hypoplasia The use of tetracycline class drugs, including EMROSI during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Permanent discoloration of the teeth is more common during long-term use of tetracycline-class drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.

Use of EMROSI is not recommended during tooth development. Advise the patient of the potential risk to the fetus if EMROSI is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1 , 8.4 )].

5.3Inhibition of Bone Growth The use of tetracycline-class drugs, including EMROSI, during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines, including EMROSI, form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human 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 EMROSI is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1 , 8.4 )].

5.4Clostridioides difficile -Associated Diarrhea (Antibiotic-Associated Colitis) Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including minocycline, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contr…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Skin/Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Clostridioides difficile -Associated Diarrhea (Antibiotic-Associated Colitis) [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Central Nervous System Effects [see Warnings and Precautions (5.6) ] Idiopathic Intracranial Hypertension [see Warnings and Precautions (5.7) ] The most commonly observed adverse reaction (incidence ≥1%) is dyspepsia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859 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. In two clinical trials, MVOR-1 and MVOR-2, a total of 638 adult subjects were analyzed under the safety population with 243 subjects in EMROSI group, 237 subjects in doxycycline (40 mg) group and 158 subjects in placebo group [see Clinical Studies (14) ].

The most common adverse reaction reported by ≥1% of subjects treated with EMROSI and more frequently than in subjects receiving placebo was dyspepsia, which was reported in 2% of subjects treated with EMROSI and none of the subjects receiving placebo.

6.2Postmarketing Experience The following adverse reactions have been reported with post-approval use of minocycline hydrochloride in a variety of indications. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and hypersensitivity reactions: anaphylaxis, angioedema, DRESS syndrome, erythema multiforme, Stevens-Johnson syndrome, acute febrile neutrophilic dermatosis (Sweet’s syndrome), fixed drug eruptions, balanitis, anaphylactoid purpura photosensitivity, pigmentation of skin and mucous membranes.

Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, lupus-like syndrome. Central nervous system: idiopathic intracranial hypertension, bulging fontanels in infants, decreased hearing. Endocrine: brown-black microscopic thyroid discoloration, abnormal thyroid function.

Oncology: thyroid cancer. Oral: glossitis, dysphagia, tooth discoloration. Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure.

Renal: acute renal failure. Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

🔄 Drug Interactions 105 words ▾

7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 )

7.1Anticoagulants Because tetracyclines have been shown to decrease plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

7.2Penicillin Because bacteriostatic drugs may interfere with the bactericidal action of penicillin, avoid giving EMROSI in conjunction with penicillin.

7.3Antacids and Iron Preparations Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.

7.4Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended. ( 8.2 )

8.1Pregnancy Risk Summary Tetracycline-class drugs, including EMROSI, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.2 , 5.3 ) and Use in Specific Populations (8.4) ]. A few postmarketing cases of limb reductions have been reported over decades of use; however, the association is unclear. The limited data from postmarketing reports are not sufficient to inform a drug-associated risk for birth defects or miscarriage.

In animal reproduction studies conducted in pregnant rats and rabbits, bent limb bones were observed following oral administration of minocycline hydrochloride during organogenesis at systemic exposure of approximately 7.1 and 4.8 times, respectively, the maximum recommended human dose (MRHD) based on AUC exposures (see Data ). If the patient becomes pregnant while taking this drug, advise the patient of the risk to the fetus and discontinue treatment. 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. Data Human Data The use of tetracycline class drugs, including EMROSI, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of deciduous teeth (yellow-gray-brown).

Permanent discoloration of the teeth is more common during long-term use of the drug but has been observed following repeated short-term courses [see Warnings and Precautions (5.2) ]. Animal Data Results of animal studies indicate that minocycline hydrochloride crosses the placenta, are found in fetal tissues, and can cause delayed skeletal development in the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Warnings and Precautions (5.3) ].

Minocycline hydrochloride induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (7.1 and 4.8 times, respectively, the MRHD based on AUC comparison). Reduced mean fetal body weight was observed in studies in which minocycline hydrochloride was administered to pregnant rats at an oral dose of 10 mg/kg/day (2.4 times the MRHD based on AUC comparison). Minocycline hydrochloride was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation at doses of 5, 10, or 50 mg/kg/day.

In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (6 times the MRHD based on AUC comparison). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in offspring of animals that received minocycline hydrochloride at 50 mg/kg/day included reduced body size, improperly rotated forelimbs, and reduced size of extremities.

No effects were observed on the physical development, behavior, learning ability, or reproduction of the offspring of animals that received minocycline hydrochloride.

8.2Lactation Risk Summary Tetracycline-class antibiotics, including minocycline, are present in breast milk following oral administration. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommen…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Tetracycline-class drugs, including EMROSI, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.2 , 5.3 ) and Use in Specific Populations (8.4) ]. A few postmarketing cases of limb reductions have been reported over decades of use; however, the association is unclear. The limited data from postmarketing reports are not sufficient to inform a drug-associated risk for birth defects or miscarriage.

In animal reproduction studies conducted in pregnant rats and rabbits, bent limb bones were observed following oral administration of minocycline hydrochloride during organogenesis at systemic exposure of approximately 7.1 and 4.8 times, respectively, the maximum recommended human dose (MRHD) based on AUC exposures (see Data ). If the patient becomes pregnant while taking this drug, advise the patient of the risk to the fetus and discontinue treatment. 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. Data Human Data The use of tetracycline class drugs, including EMROSI, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of deciduous teeth (yellow-gray-brown).

Permanent discoloration of the teeth is more common during long-term use of the drug but has been observed following repeated short-term courses [see Warnings and Precautions (5.2) ]. Animal Data Results of animal studies indicate that minocycline hydrochloride crosses the placenta, are found in fetal tissues, and can cause delayed skeletal development in the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Warnings and Precautions (5.3) ].

Minocycline hydrochloride induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (7.1 and 4.8 times, respectively, the MRHD based on AUC comparison). Reduced mean fetal body weight was observed in studies in which minocycline hydrochloride was administered to pregnant rats at an oral dose of 10 mg/kg/day (2.4 times the MRHD based on AUC comparison). Minocycline hydrochloride was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation at doses of 5, 10, or 50 mg/kg/day.

In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (6 times the MRHD based on AUC comparison). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in offspring of animals that received minocycline hydrochloride at 50 mg/kg/day included reduced body size, improperly rotated forelimbs, and reduced size of extremities.

No effects were observed on the physical development, behavior, learning ability, or reproduction of the offspring of animals that received minocycline hydrochloride.

🧒 Pediatric Use 44 words ▾

8.4Pediatric Use The safety and effectiveness of EMROSI have not been established in pediatric patients. Tooth discoloration and inhibition of bone growth have been observed in pediatric patients with the use of tetracycline class antibiotics [see Warnings and Precaution (5.2 , 5.3 )].

🧓 Geriatric Use 59 words ▾

8.5Geriatric Use Of the 653 subjects in the phase 3 clinical trials of EMROSI, 101 (15.5%) subjects were 65 years of age and older and 25 (3.8%) were 75 years of age and older. No overall differences in safety or effectiveness of EMROSI have been observed between subjects 65 years of age and older and younger adult subjects.

🆘 Overdosage 36 words ▾

10 OVERDOSAGE Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis. In case of overdosage, discontinue EMROSI, treat symptomatically and institute supportive measures. Call Poison Control Center at 1-800-222-1222 for the latest recommendations.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of EMROSI for the treatment of rosacea is unknown.

12.2Pharmacodynamics The pharmacodynamics of EMROSI for the treatment of rosacea are unknown.

12.3Pharmacokinetics EMROSI is not bioequivalent to any other minocycline products. The pharmacokinetics of minocycline following administration of EMROSI was investigated in two studies that enrolled 32 healthy, adult subjects. In Study 1, the plasma pharmacokinetic parameters for EMROSI following single dose administration under fasting and fed states are presented in Table 1 .

Table 1: Plasma Pharmacokinetic Parameters [Mean (%CV)] for EMROSI (40 mg) N C max (ng/mL) T max * (hr) AUC inf (ng.hr/mL) t 1/2 (hr) EMROSI (Fasting) 23 243.9 (37.3) 1.50 (1.00 – 4.17) 3933.6 (31.2) 14.67 (26.7) EMROSI (Fed) 23 225.0 (16.7) 4.50 (3.00 – 8.00) 4404.1 (21.0) 14.93 (21.5) Note: * Median (Range) In Study 2, minocycline plasma PK following EMROSI single (Day 1) and after repeated (Day 21) once daily administrations in eight (8) subjects were found to be similar with overlapping ranges. The mean C max was 382.83 ng/mL versus 337.74 ng/mL and AUC 0-24 was 3549.64 ng*hr/mL versus 3957.62 ng*hr/mL, respectively on Day 1 versus Day 21.

Absorption: In Study 1, the median plasma T max of minocycline from EMROSI was 1.50 hours (1.00 - 4.17). In Study 2, the median plasma T max values of minocycline from EMROSI on Day 1 and Day 21 were 1.75 and 1.5 hours, respectively. Effect of Food: Following administration of EMROSI with a high-fat meal (1011 Kcal, 53% fat), T max was delayed by approximately 3 hours.

The high fat meal did not impact the C max however, the AUC inf was increased by 15.26% ( Table 1 ) [see Dosage and Administration (2) ]. Distribution: Minocycline is lipid soluble and distributes into the skin and sebum. In Study 1, the mean apparent volume of distribution (Vz/F) values of minocycline following oral administration of EMROSI at fasting and fed condition were 229.61 (±67.83) L and 199.83 (±43.71) L, respectively.

Elimination: The mean apparent elimination half-life (t ½ ) of minocycline from EMROSI was approximately 15 hours independent of fasting and fed dosing condition.

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action The mechanism of action of EMROSI for the treatment of rosacea is unknown.

📦 How Supplied / Storage and Handling 70 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied EMROSI is an opaque, brownish-red colored, hard gelatin capsule, imprinted “MEC” on both cap and body with white ink. Bottles of 30 capsules with child-resistant closure, NDC 69489-131-30. Storage and Handling Store at room temperature 20°C to 25°C (68°F to 77°F); excursions are permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from light, moisture, and excessive heat.

📋 Description 155 words ▾

11 DESCRIPTION Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a- tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. Its molecular formula is C 23 H 27 N 3 O 7 •HCl with a molecular weight of 493.95. Minocycline hydrochloride has the following structure: Minocycline hydrochloride is a yellow, hygroscopic, crystalline powder.

It is sparingly soluble in water, slightly soluble in ethanol (96%). A 1% w/v solution in water has pH between 3.5 and 4.5. Each EMROSI extended-release capsule contains 40 mg of minocycline (equivalent to 43.19 mg of minocycline hydrochloride) as 10 mg immediate-release and 30 mg extended-release beads and the following inactive ingredients: ethyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, Opadry ® clear, polyethylene glycol 400, triethyl citrate and talc.

Opadry ® clear contains: hydroxypropyl cellulose and hypromellose. Capsule shell contains gelatin, iron oxide red and titanium dioxide. White ink contains ammonia, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, titanium dioxide and shellac. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise patients taking EMROSI extended-release capsules of the following information and instructions: Administration Instructions EMROSI should be taken exactly as directed. Advise patients to swallow EMROSI capsule whole and not to chew or crush the capsule [see Dosage and Administration (2) ].

Serious Skin/Hypersensitivity Reactions Inform patients that serious skin reactions have occurred with minocycline use in patients with acne. Advise patients to discontinue use of EMROSI and contact their healthcare provider immediately at the first evidence of skin erythema [see Warnings and Precautions (5.1) ]. Tooth Discoloration and Enamel Hypoplasia Advise patients that EMROSI use in pregnancy may cause permanent tooth discoloration of deciduous teeth.

Advise patients to discontinue EMROSI during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions (5.2) , Use in Specific Populations (8.1) ]. Inhibition of Bone Growth Advise patients that EMROSI use in pregnancy may cause inhibition of fetal bone growth. Advise patients to discontinue EMROSI during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions (5.3) , Use in Specific Populations (8.1) ].

Clostridioides difficile -Associated Diarrhea (Antibiotic-Associated Colitis) Advise patients that Clostridioides difficile -associated diarrhea (antibiotic-associated colitis) can occur with minocycline therapy, including EMROSI. If patients develop watery or bloody stools, advise patients to seek medical attention [see Warnings and Precautions (5.4) ]. Hepatotoxicity Inform patients about the possibility of hepatotoxicity.

Advise patients to seek medical advice if they experience signs or symptoms of hepatotoxicity, including loss of appetite, tiredness, diarrhea, jaundice, bleeding easily, confusion, and sleepiness [see Warnings and Precautions (5.5) ]. Central Nervous System Effects Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with oral minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on EMROSI [see Warnings and Precautions (5.6) ].

Idiopathic Intracranial Hypertension Inform patients that idiopathic intracranial hypertension can occur with minocycline therapy. Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss [see Warnings and Precautions (5.7) ]. Autoimmune Syndromes Inform patients that autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis, and serum sickness have been observed with tetracycline-class drugs, including minocycline.

Symptoms may be manifested by arthralgia, fever, rash, and malaise. Advise patients who experience such symptoms to immediately discontinue EMROSI and seek medical help [see Warnings and Precautions (5.8) ]. Photosensitivity Inform patients that photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline.

Advise patients to minimize or avoid exposure to natural or artificial sunlight (i.e., tanning beds or UVA/B treatment) while using EMROSI. Instruct patients to use sunscreen and wear protective clothing (e.g., hat) over treated areas when exposure to sun cannot be avoided [see Warnings and Precautions (5.10) ]. Tissue Hyperpigmentation Inform patients that EMROSI may cause discoloration of skin, scars, teeth, or gums [see Warnings and Precautions (5.11) ] .

Lactation Advise patients that EMROSI therapy is not recommended during breast feeding for 4 days after the final dose [see Use in Specific Populations (8.2) ]. Manuf…

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