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Purified Cortrophin Gel Repository Corticotropin 80 [USP'U]/mL Injection, 1 vial — NDC 62559-0860-11 package photo

Purified Cortrophin Gel Repository Corticotropin 80 [USP'U]/mL Injection, 1 vial

by ANI Pharmaceuticals, Inc. · 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-11) / 1 mL in 1 VIAL, MULTI-DOSE
NDC 62559-0860-11
🏷️ FDA NDC (as labeled) 62559-860-11 billing pads the product segment with a zero
This package
Contains1 vial Pack sizes2 compare ↓
Also priced by: Part D plans $7,137.38/unit — full pricing hub ↓
Also comes in: 5 mL 62559-0860-15
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

⚠️
Other active recalls for Repository Corticotropin (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — Presence of particulate matter: glass and stopper piece (Mallinckrodt Hospital Products Inc.) · FDA recall D-0803-2026
Class II · Feb 6, 2024 — cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified. (Mallinckrodt Hospital Products Inc.) · FDA recall D-0340-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 62559-860-11
Product NDC 62559-860
11-digit billing NDC 62559086011
NCPDP billing unit ML — per mL (volume)
RxCUI 309541, 2584475, 2685293, 2685298, 2707578, 2707580
UNII K0U68Q2TXA
UPC 0046211000095, 0362559860116
Application # NDA008975
SPL Set ID f27544ee-a0e2-4d84-b193-1c9efdf9e34c
Established class (EPC) Adrenocorticotropic Hormone
Chemical class Adrenocorticotropic Hormone
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-29
Route INTRAMUSCULAR, SUBCUTANEOUS
Dosage form INJECTION
Substance CORTICOTROPIN
GPI-14 30300010004010
GPI class Cortrophin
GCN Seq No 006597
GCN 26016
HICL code 002830
Ingredient (HICL) Corticotropin
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P1
Therapeutic class — intermediate (HIC2) Anteriorpituitary Hormones
HIC3 code P1E
Therapeutic class — specific (HIC3) Adrenocorticotrophic Hormones
AHFS code 36:04.00.00
AHFS class Adrenocortical Insufficiency
FDB label name CORTROPHIN GEL 80 UNIT/ML VIAL
FDB brand name Cortrophin
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 62559-860-11 — 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 → 62559-0860-11. 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 Adrenocorticotropic Hormone class.

Pharmacologic class Adrenocorticotropic Hormone
Drug family (ATC) Acth
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

LabelerANI Pharmaceuticals, Inc.
Application holderANI PHARMACEUTICALS INC
FDA applicationNDA008975 (NDA)
Labeler code62559
First marketedOct 2021
Product typeHuman Prescription Drug
Portfolio299 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 CORTROPHIN GEL 80 UNIT/ML VIAL Ingredient Corticotropin
📖 What it is MedlinePlus · NLM

Corticotropin repository injection is used to treat the following conditions: infantile spasms (seizures that usually begin during the first year of life and may be followed by developmental delays) in infants and children younger than 2 years of age; episodes of symptoms in people who have multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control); episodes of symptoms in people who have rheumatoid arthritis (a condition in which the body a...

Read the full MedlinePlus article ↗

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.

🧪 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 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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 339NCG44TV
    Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 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 $7,137.38 $7,137.38 / 1 vial
Medicare Part B allowsASP · J0802 $3,674.678 / J0802 unit —
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)62559-860-11
11-digit billing NDC62559-0860-11
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0802
DescriptorInjection, corticotropin (ani), up to 40 units
Billing units / pkg2 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Purified Cortrophin Gel 80 [USP'U]/mLthis 62559-0860-11 ANI 1 vial — — FDA listed —
Acthar 80 [USP'U]/mL 63004-8710-01 Mallinckrodt 1 vial — — 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

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2043
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 2043. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approval date not confirmed RLD RS ⏳ ~17.1 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 12440542 — method of use (U-3910)
US 12440542 — method of use (U-3911)
US 12440542 — method of use (U-3904)
US 12440542 — method of use (U-3905)
US 12440542 — method of use (U-3906)
US 12440542 — method of use (U-3907)
US 12440542 — method of use (U-3908)
US 12440542 — method of use (U-3909)
US 12440542 — method of use (U-3912)
US 12440542 — method of use (U-3913)
US 12440542 — method of use (U-3914)
US 12440542 — method of use (U-3915)
US 12440542 — method of use (U-3916)
US 12102662 — method of use (U-3916)
US 12102662 — method of use (U-3917)
US 12102662 — method of use (U-3917)
US 12102662 — method of use (U-3918)
US 12102662 — method of use (U-3918)
US 12102662 — method of use (U-3919)
US 12102662 — method of use (U-3919)
US 12102662 — method of use (U-3920)
US 12102662 — method of use (U-3920)
US 12102662 — method of use (U-3921)
US 12102662 — method of use (U-3921)
US 12102662 — method of use (U-3922)
US 12102662 — method of use (U-3922)
US 12102662 — method of use (U-3923)
US 12102662 — method of use (U-3923)
US 12102662 — method of use (U-3924)
US 12102662 — method of use (U-3924)
US 12102662 — method of use (U-3925)
US 12102662 — method of use (U-3925)
US 12102662 — method of use (U-3926)
US 12102662 — method of use (U-3926)
US 12102662 — method of use (U-3904)
US 12102662 — method of use (U-3904)
US 12102662 — method of use (U-3905)
US 12102662 — method of use (U-3905)
US 12102662 — method of use (U-3906)
US 12102662 — method of use (U-3906)
US 12102662 — method of use (U-3907)
US 12102662 — method of use (U-3907)
US 12102662 — method of use (U-3908)
US 12102662 — method of use (U-3908)
US 12102662 — method of use (U-3909)
US 12102662 — method of use (U-3909)
US 12102662 — method of use (U-3910)
US 12102662 — method of use (U-3910)
US 12102662 — method of use (U-3911)
US 12102662 — method of use (U-3911)
US 12102662 — method of use (U-3912)
US 12102662 — method of use (U-3912)
US 12102662 — method of use (U-3913)
US 12102662 — method of use (U-3913)
US 12102662 — method of use (U-3914)
US 12102662 — method of use (U-3914)
US 12102662 — method of use (U-3915)
US 12102662 — method of use (U-3915)
US 12102662 — method of use (U-3916)
US 12440542 — method of use (U-3917)
US 12440542 — method of use (U-3918)
US 12440542 — method of use (U-3919)
US 12440542 — method of use (U-3920)
US 12440542 — method of use (U-3921)
US 12440542 — method of use (U-3922)
US 12440542 — method of use (U-3923)
US 12440542 — method of use (U-3924)
US 12440542 — method of use (U-3925)
US 12440542 — method of use (U-3926)
US 12233105 — method of use (U-3912)
US 12233105 — method of use (U-3913)
US 12233105 — method of use (U-3914)
US 12233105 — method of use (U-3915)
US 12233105 — method of use (U-3916)
US 12233105 — method of use (U-3917)
US 12233105 — method of use (U-3918)
US 12233105 — method of use (U-3919)
US 12233105 — method of use (U-3920)
US 12233105 — method of use (U-3921)
US 12233105 — method of use (U-3922)
US 12233105 — method of use (U-3923)
US 12233105 — method of use (U-3924)
US 12233105 — method of use (U-3925)
US 12233105 — method of use (U-3926)
US 12233105 — method of use (U-3904)
US 12233105 — method of use (U-3905)
US 12233105 — method of use (U-3906)
US 12233105 — method of use (U-3907)
US 12233105 — method of use (U-3908)
US 12233105 — method of use (U-3909)
US 12233105 — method of use (U-3910)
US 12233105 — method of use (U-3911)
US 11975047 — method of use (U-3904)
US 11975047 — method of use (U-3905)
US 11975047 — method of use (U-3906)
US 11975047 — method of use (U-3907)
US 11975047 — method of use (U-3908)
US 11975047 — method of use (U-3909)
US 11975047 — method of use (U-3910)
US 11975047 — method of use (U-3911)
US 11975047 — method of use (U-3912)
US 11975047 — method of use (U-3913)
US 11975047 — method of use (U-3914)
US 11975047 — method of use (U-3915)
US 11975047 — method of use (U-3916)
US 11975047 — method of use (U-3917)
US 11975047 — method of use (U-3918)
US 11975047 — method of use (U-3919)
US 11975047 — method of use (U-3920)
US 11975047 — method of use (U-3921)
US 11975047 — method of use (U-3922)
US 11975047 — method of use (U-3923)
US 11975047 — method of use (U-3924)
US 11975047 — method of use (U-3925)
US 11975047 — method of use (U-3926)
US 12324787 — drug product
2041 2043
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 (116)
PatentTypeUse codeExpires
US 12440542 ↗ Method of use U-3910 Oct 27, 2043
US 12440542 ↗ Method of use U-3911 Oct 27, 2043
US 12440542 ↗ Method of use U-3904 Oct 27, 2043
US 12440542 ↗ Method of use U-3905 Oct 27, 2043
US 12440542 ↗ Method of use U-3906 Oct 27, 2043
US 12440542 ↗ Method of use U-3907 Oct 27, 2043
US 12440542 ↗ Method of use U-3908 Oct 27, 2043
US 12440542 ↗ Method of use U-3909 Oct 27, 2043
US 12440542 ↗ Method of use U-3912 Oct 27, 2043
US 12440542 ↗ Method of use U-3913 Oct 27, 2043
US 12440542 ↗ Method of use U-3914 Oct 27, 2043
US 12440542 ↗ Method of use U-3915 Oct 27, 2043
US 12440542 ↗ Method of use U-3916 Oct 27, 2043
US 12102662 ↗ Method of use U-3916 Oct 27, 2043
US 12102662 ↗ Method of use U-3917 Oct 27, 2043
US 12102662 ↗ Method of use U-3917 Oct 27, 2043
US 12102662 ↗ Method of use U-3918 Oct 27, 2043
US 12102662 ↗ Method of use U-3918 Oct 27, 2043
US 12102662 ↗ Method of use U-3919 Oct 27, 2043
US 12102662 ↗ Method of use U-3919 Oct 27, 2043
US 12102662 ↗ Method of use U-3920 Oct 27, 2043
US 12102662 ↗ Method of use U-3920 Oct 27, 2043
US 12102662 ↗ Method of use U-3921 Oct 27, 2043
US 12102662 ↗ Method of use U-3921 Oct 27, 2043
US 12102662 ↗ Method of use U-3922 Oct 27, 2043
US 12102662 ↗ Method of use U-3922 Oct 27, 2043
US 12102662 ↗ Method of use U-3923 Oct 27, 2043
US 12102662 ↗ Method of use U-3923 Oct 27, 2043
US 12102662 ↗ Method of use U-3924 Oct 27, 2043
US 12102662 ↗ Method of use U-3924 Oct 27, 2043
US 12102662 ↗ Method of use U-3925 Oct 27, 2043
US 12102662 ↗ Method of use U-3925 Oct 27, 2043
US 12102662 ↗ Method of use U-3926 Oct 27, 2043
US 12102662 ↗ Method of use U-3926 Oct 27, 2043
US 12102662 ↗ Method of use U-3904 Oct 27, 2043
US 12102662 ↗ Method of use U-3904 Oct 27, 2043
US 12102662 ↗ Method of use U-3905 Oct 27, 2043
US 12102662 ↗ Method of use U-3905 Oct 27, 2043
US 12102662 ↗ Method of use U-3906 Oct 27, 2043
US 12102662 ↗ Method of use U-3906 Oct 27, 2043
US 12102662 ↗ Method of use U-3907 Oct 27, 2043
US 12102662 ↗ Method of use U-3907 Oct 27, 2043
US 12102662 ↗ Method of use U-3908 Oct 27, 2043
US 12102662 ↗ Method of use U-3908 Oct 27, 2043
US 12102662 ↗ Method of use U-3909 Oct 27, 2043
US 12102662 ↗ Method of use U-3909 Oct 27, 2043
US 12102662 ↗ Method of use U-3910 Oct 27, 2043
US 12102662 ↗ Method of use U-3910 Oct 27, 2043
US 12102662 ↗ Method of use U-3911 Oct 27, 2043
US 12102662 ↗ Method of use U-3911 Oct 27, 2043
US 12102662 ↗ Method of use U-3912 Oct 27, 2043
US 12102662 ↗ Method of use U-3912 Oct 27, 2043
US 12102662 ↗ Method of use U-3913 Oct 27, 2043
US 12102662 ↗ Method of use U-3913 Oct 27, 2043
US 12102662 ↗ Method of use U-3914 Oct 27, 2043
US 12102662 ↗ Method of use U-3914 Oct 27, 2043
US 12102662 ↗ Method of use U-3915 Oct 27, 2043
US 12102662 ↗ Method of use U-3915 Oct 27, 2043
US 12102662 ↗ Method of use U-3916 Oct 27, 2043
US 12440542 ↗ Method of use U-3917 Oct 27, 2043
US 12440542 ↗ Method of use U-3918 Oct 27, 2043
US 12440542 ↗ Method of use U-3919 Oct 27, 2043
US 12440542 ↗ Method of use U-3920 Oct 27, 2043
US 12440542 ↗ Method of use U-3921 Oct 27, 2043
US 12440542 ↗ Method of use U-3922 Oct 27, 2043
US 12440542 ↗ Method of use U-3923 Oct 27, 2043
US 12440542 ↗ Method of use U-3924 Oct 27, 2043
US 12440542 ↗ Method of use U-3925 Oct 27, 2043
US 12440542 ↗ Method of use U-3926 Oct 27, 2043
US 12233105 ↗ Method of use U-3912 Oct 27, 2043
US 12233105 ↗ Method of use U-3913 Oct 27, 2043
US 12233105 ↗ Method of use U-3914 Oct 27, 2043
US 12233105 ↗ Method of use U-3915 Oct 27, 2043
US 12233105 ↗ Method of use U-3916 Oct 27, 2043
US 12233105 ↗ Method of use U-3917 Oct 27, 2043
US 12233105 ↗ Method of use U-3918 Oct 27, 2043
US 12233105 ↗ Method of use U-3919 Oct 27, 2043
US 12233105 ↗ Method of use U-3920 Oct 27, 2043
US 12233105 ↗ Method of use U-3921 Oct 27, 2043
US 12233105 ↗ Method of use U-3922 Oct 27, 2043
US 12233105 ↗ Method of use U-3923 Oct 27, 2043
US 12233105 ↗ Method of use U-3924 Oct 27, 2043
US 12233105 ↗ Method of use U-3925 Oct 27, 2043
US 12233105 ↗ Method of use U-3926 Oct 27, 2043
US 12233105 ↗ Method of use U-3904 Oct 27, 2043
US 12233105 ↗ Method of use U-3905 Oct 27, 2043
US 12233105 ↗ Method of use U-3906 Oct 27, 2043
US 12233105 ↗ Method of use U-3907 Oct 27, 2043
US 12233105 ↗ Method of use U-3908 Oct 27, 2043
US 12233105 ↗ Method of use U-3909 Oct 27, 2043
US 12233105 ↗ Method of use U-3910 Oct 27, 2043
US 12233105 ↗ Method of use U-3911 Oct 27, 2043
US 11975047 ↗ Method of use U-3904 Oct 27, 2043
US 11975047 ↗ Method of use U-3905 Oct 27, 2043
US 11975047 ↗ Method of use U-3906 Oct 27, 2043
US 11975047 ↗ Method of use U-3907 Oct 27, 2043
US 11975047 ↗ Method of use U-3908 Oct 27, 2043
US 11975047 ↗ Method of use U-3909 Oct 27, 2043
US 11975047 ↗ Method of use U-3910 Oct 27, 2043
US 11975047 ↗ Method of use U-3911 Oct 27, 2043
US 11975047 ↗ Method of use U-3912 Oct 27, 2043
US 11975047 ↗ Method of use U-3913 Oct 27, 2043
US 11975047 ↗ Method of use U-3914 Oct 27, 2043
US 11975047 ↗ Method of use U-3915 Oct 27, 2043
US 11975047 ↗ Method of use U-3916 Oct 27, 2043
US 11975047 ↗ Method of use U-3917 Oct 27, 2043
US 11975047 ↗ Method of use U-3918 Oct 27, 2043
US 11975047 ↗ Method of use U-3919 Oct 27, 2043
US 11975047 ↗ Method of use U-3920 Oct 27, 2043
US 11975047 ↗ Method of use U-3921 Oct 27, 2043
US 11975047 ↗ Method of use U-3922 Oct 27, 2043
US 11975047 ↗ Method of use U-3923 Oct 27, 2043
US 11975047 ↗ Method of use U-3924 Oct 27, 2043
US 11975047 ↗ Method of use U-3925 Oct 27, 2043
US 11975047 ↗ Method of use U-3926 Oct 27, 2043
US 12324787 ↗ Drug product — Oct 27, 2043
Common questions
Is there a generic version of CORTROPHIN GEL 80 UNIT/ML VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for CORTROPHIN GEL 80 UNIT/ML VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2043 — 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.

💊 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.
1 vial62559-0860-15 427 Rx · $25,305,729
1 vial this page62559-0860-11 No Medicaid data
Drug total (last 4 qtrs): 427 Rx · 3,663 units · $25,305,729 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
62559-0860-15 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-15) / 5 mL in 1 VIAL, MULTI-DOSE 2021-10-29 Active
62559-0860-11 You're viewing this 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-11) / 1 mL in 1 VIAL, MULTI-DOSE 2023-08-14 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 62559-0860-11?
NDC 62559-0860-11 contains 1 vial — 1 vial, multi-dose in 1 carton / 1 ml in 1 vial, multi-dose.
What NDC number is used to bill for this package of Purified Cortrophin Gel Repository Corticotropin 80 [USP'U]/mL Injection?
Bill NDC 62559-0860-11 — the 11-digit billing format is 62559086011. 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 ✓ Available
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 62559-860-11, 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: 62559-0860-11, written without dashes as 62559086011. 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 62559-0860-11, the first segment (62559) is the labeler code FDA assigned to ANI Pharmaceuticals, Inc.; the middle segment (0860) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) 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 ANI 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 1 vial (62559-0860-15). 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?
ANI 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0802 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 166 words ▾

INDICATIONS AND USAGE Purified Cortrophin Gel is indicated in the following disorders: 1. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).

Ankylosing spondylitis. Acute gouty arthritis. 2.

Collagen diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). 3.

Dermatologic diseases: Severe erythema multiforme (Stevens-Johnson syndrome). Severe psoriasis. 4.

Allergic states: Atopic dermatitis Serum sickness. 5. Ophthalmic diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis.

Keratitis. Iritis and iridocyclitis. Diffuse posterior uveitis and choroiditis.

Optic neuritis. Chorioretinitis. Anterior segment inflammation.

6. Respiratory diseases: Symptomatic sarcoidosis. 7.

Edematous states: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus. 8. Nervous system: Acute exacerbations of multiple sclerosis.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Standard tests for verification of adrenal responsiveness to corticotropin may utilize as much as 80 units as a single injection or one or more injections of a lesser dosage. Verification tests should be performed prior to treatment with corticotropins. The test should utilize the route(s) of administration proposed for treatment.

Following verification dosage should be individualized according to the disease under treatment and the general medical condition of each patient. Frequency and dose of the drug should be determined by considering severity of the disease, plasma and urine corticosteroid levels and the initial response of the patient. Only gradual change in dosage schedules should be attempted, after full drug effects have become apparent.

This product may be administered subcutaneously or intramuscularly with the vial and subcutaneously with the prefilled syringe. In the treatment of acute exacerbations of multiple sclerosis daily subcutaneous or intramuscular doses of 80-120 units for 2-3 weeks. The chronic administration of more than 40 units daily may be associated with uncontrollable adverse effects.

When reduction in dosage is indicated this should be accomplished gradually by either reducing the amount of each injection, or administering injections at longer intervals, or by a combination of both of the above. During reduction of dosage, careful consideration should be given to the disease being treated, the general medical condition of the patient and the duration over which corticotropin was administered. Important Administration Instructions • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Purified Cortrophin Gel is a clear, light amber liquid gel at room temperature. Do not use if the solution is discolored or cloudy or the solution contains particulate matter. • Purified Cortrophin Gel will be a solid gel when refrigerated and needs to be warmed to a liquid gel before administration. o For Purified Cortrophin Gel vials warm by rolling between your hands for a few minutes. o For Purified Cortrophin Gel prefilled syringes remove the carton from the refrigerator and leave at room temperature for 45 minutes. • The recommended injection sites include abdomen, upper thigh, or upper arm.

Do not inject within 2 inches of navel. Information for Patients Advise patients and/or caregivers to read the FDA-approved patient information (Instructions for Use).

⛔ Contraindications 62 words ▾

CONTRAINDICATIONS Purified Cortrophin Gel is contraindicated for intravenous administration. Purified Cortrophin Gel is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, hypertension, or sensitivity to proteins derived from porcine sources. Purified Cortrophin Gel is contraindicated in patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.

⚠️ Warnings ~2 min read ▾

WARNINGS Chronic administration of corticotropin may lead to adverse effects which are not reversible. This product should not be administered for treatment until adrenal responsiveness has been verified with the route of administration which will be utilized during treatment, intramuscularly or subcutaneously. A rise in urinary and plasma corticosteroid values provides direct evidence of a stimulatory effect.

Although the action of corticotropin is similar to that of exogenous adrenocortical steroids the quantity of adrenocorticoid may be variable. In patients who receive prolonged corticotropin therapy the additional use of rapidly acting corticosteroids before, during and after an unusual stressful situation is indicated. Masking Symptoms of Other Diseases Corticotropin may only suppress symptoms and signs of chronic disease without altering the natural course of the disease.

Immunogenicity Potential Purified Cortrophin Gel is immunogenic. Limited available data suggest that a patient may develop antibodies to Purified Cortrophin Gel after chronic administration and loss of endogenous ACTH and Purified Cortrophin Gel activity. Prolonged administration of Purified Cortrophin Gel may increase the risk of hypersensitivity reactions.

Cases of anaphylaxis following administration have also been reported in the postmarketing setting. Sensitivity to porcine protein should be considered before starting therapy and during the course of treatment should symptoms arise. Ophthalmic Effects Prolonged use of corticotropin may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves.

Infections Corticotropin may mask some signs of infection, and new infections including those of the eye due to fungi or viruses may appear during its use. There may be decreased resistance and inability to localize infection when corticotropin is used. Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia Corticotropin can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.

Dietary salt restriction and potassium supplementation may be necessary. Corticotropin increases calcium excretion. Vaccination While on corticotropin therapy, patients should not be vaccinated against smallpox.

Other immunization procedures should be undertaken with caution in patients who are receiving corticotropin, especially when high doses are administered because of the possible hazards of neurological complications and lack of antibody response.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Fluid and Electrolyte Disturbances Sodium retention. Hypokalemic alkalosis. Fluid retention.

Calcium loss. Potassium loss. Musculoskeletal Muscle weakness.

Loss of muscle mass. Steroid myopathy. Osteoporosis.

Vertebral compression fractures. Aseptic necrosis of femoral and humeral heads. Pathologic fracture of long bones.

Gastrointestinal Peptic ulcer with possible perforation and hemorrhage. Abdominal distention. Ulcerative esophagitis.

Pancreatitis. Dermatologic Injection site reactions. Impaired wound healing.

Increased sweating. Thin fragile skin. Suppression of skin test reactions.

Petechiae and ecchymoses. Acne. Hyperpigmentation.

Facial erythema. Cardiovascular Hypertension. Congestive heart failure.

Necrotizing angiitis. Neurological Convulsions. Increased intracranial pressure with papilledema (pseudo-tumor cerebri), usually after treatment.

Headache. Vertigo. Endocrine Menstrual irregularities.

Development of Cushingoid state. Suppression of growth in children. Secondary adrenocortical and pituitary insufficiency, particularly in times of stress, as in trauma, surgery or illness.

Decreased carbohydrate tolerance. Manifestations of latent diabetes mellitus. Increased requirements for insulin or oral hypoglycemic agents in diabetics.

Hirsutism. Ophthalmic Posterior subcapsular cataracts. Increased intraocular pressure.

Glaucoma with possible damage to optic nerve. Exophthalmos. Metabolic Negative nitrogen balance due to protein catabolism.

Allergic reactions Allergic reactions manifesting as dizziness, nausea and vomiting, skin reactions, anaphylaxis (anaphylactic shock, urticaria, respiratory compromise, edema), especially in patients with allergic responses to proteins. Miscellaneous Weight gain. Abscess.

Development of antibodies and loss of stimulatory effect. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 13 words ▾

Drug Interactions Aspirin should be used cautiously in conjunction with corticotropin in hypoprothrombinemia.

🤰 Pregnancy 65 words ▾

Pregnancy Since fetal abnormalities have been observed in experimental animals, use of this drug in pregnancy, nursing mothers, or women of childbearing potential requires that the potential benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticotropin during pregnancy should be carefully observed for signs of hypoadrenalism.

🧬 Clinical Pharmacology 71 words ▾

CLINICAL PHARMACOLOGY Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones. Following administration of a single intramuscular injection of 80 Units of Cortrophin Gel to healthy volunteers (n=20) in an open label pharmacodynamic study, the median time (range) to reach peak cortisol concentration was 8 (3-12) hours. The baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

📦 How Supplied / Storage and Handling 85 words ▾

HOW SUPPLIED/ STORAGE AND HANDLING Purified Cortrophin Gel is a clear, light amber liquid gel at room temperature. It is supplied sterile in: • Multiple-dose vials for intramuscular or subcutaneous use Package Size Total Volume NDC 1 mL multiple-dose vial 80 USP units/mL 62559-860-11 5 mL multiple-dose vial 400 USP units/5 mL 62559-860-15 • Single-dose prefilled syringes for subcutaneous use only Package Size Total Volume NDC 0.5 mL single-dose prefilled syringe 40 USP units/0.5 mL 62559-861-35 1 mL single-dose prefilled syringe 80 USP units/mL 62559-861-11

📦 Storage and Handling 146 words ▾

Storage Store Purified Cortrophin Gel vials and prefilled syringes refrigerated at 2° to 8°C (36° to 46°F). Purified Cortrophin Gel vials and prefilled syringes may be stored at room temperature between 20° to 25°C (68° to 77°F) for up to 24 hours. After first use discard Purified Cortrophin Gel vials per the table below.

Write the revised expiration date in the space provided on the carton labeling. Package Size Discard By 1 mL multiple-dose vial 6 months after first use or by the expiration date stamped on the vial, whichever occurs first. 5 mL multiple-dose vial 28 days after first use or by the expiration date stamped on the vial, whichever occurs first.

Discard Purified Cortrophin Gel prefilled syringes immediately after use or by the expiration date stamped on the syringe. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 10233 Rev 08/25 10716 Rev 08/25 logo

📋 Description 91 words ▾

DESCRIPTION Purified Cortrophin Gel is a porcine derived purified corticotropin (ACTH) in a sterile solution of gelatin. It is made up of a complex mixture of ACTH, ACTH related peptides and other porcine pituitary derived peptides. The drug product is a sterile preparation containing 80 USP units per mL and it contains 0.5% phenol (as preservative), 15.0% gelatin (for prolonged activity), water for injection, and the pH is adjusted with hydrochloric acid and sodium hydroxide.

Purified Cortrophin Gel contains the porcine derived ACTH (1-39) with the following amino acid sequence: Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62559-0830-03 · ANI 62559-0861-11 · ANI →
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.