Prescription drug · NDA
Purified Cortrophin Gel (Repository corticotropin) NDC 62559-861
Corticotropin 80 [USP'U]/mL · Injection · Subcutaneous · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-861-11 | 62559086111 | 1 SYRINGE, GLASS in 1 CARTON (62559-861-11) / 1 mL in 1 SYRINGE, GLASSMarketed from Feb 28, 2025 | |
| 62559-861-35 | 62559086135 | 1 SYRINGE, GLASS in 1 CARTON (62559-861-35) / .5 mL in 1 SYRINGE, GLASSMarketed from Feb 28, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Purified Cortrophin Gel
- Generic name (nonproprietary)
- repository corticotropin
- Active ingredients
- Corticotropin — 80 [USP'U]/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 62559
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 008975
- Marketing start
- Listing expires
- Other FDA classes
- Adrenocorticotropic Hormone (Chemical structure)
- Identifiers
- Product ID 62559-861_acbfd15f-c384-4b64-b444-33952abc3566SPL ID acbfd15f-c384-4b64-b444-33952abc3566SPL set ID f27544ee-a0e2-4d84-b193-1c9efdf9e34cRxCUI 309541, 2584475, 2685293, 2685298, 2707578, 2707580UNII K0U68Q2TXAUPC 0046211000095, 0362559860116
- Pharmacologic class
- Adrenocorticotropic Hormone
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N462559086111followed by a unit qualifier and the quantityPackage 62559-0861-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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: A…
Excerpt only. Read the full label for complete information.
About NDC 62559-861
- What is NDC 62559-861?
- 62559-861 is the product NDC for Purified Cortrophin Gel (repository corticotropin), Corticotropin 80 [USP'U]/mL injection, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Purified Cortrophin Gel (Repository Corticotropin).
- What is the active ingredient?
- Corticotropin.
- Who is the labeler?
- ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Purified Cortrophin Gel?
- 1 other product NDC are listed under this name. See all Purified Cortrophin Gel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Purified Cortrophin Gel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Purified Cortrophin Gelrepository corticotropin | Corticotropin 80 [USP'U]/mL | InjectionIntramuscular, Subcutaneous | ANI Pharmaceuticals, Inc. | 62559-860 | 62559-0860-1162559-0860-15 |
Other NDCs under NDA 008975
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Purified Cortrophin Gelrepository corticotropin | Corticotropin 80 [USP'U]/mL | InjectionIntramuscular, Subcutaneous | ANI Pharmaceuticals, Inc. | 62559-860 |