purified cortrophin gel

Generic: repository corticotropin

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name purified cortrophin gel
Generic Name repository corticotropin
Labeler ani pharmaceuticals, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR SUBCUTANEOUS
Active Ingredients

corticotropin 80 [USP'U]/mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-860
Product ID 62559-860_acbfd15f-c384-4b64-b444-33952abc3566
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA008975
Listing Expiration 2027-12-31
Marketing Start 2021-10-29

Pharmacologic Class

Established (EPC)
adrenocorticotropic hormone [epc]
Chemical Structure
adrenocorticotropic hormone [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559860
Hyphenated Format 62559-860

Supplemental Identifiers

RxCUI
309541 2584475 2685293 2685298 2707578 2707580
UPC
0046211000095 0362559860116
UNII
K0U68Q2TXA
NUI
M0000499 N0000175941

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name purified cortrophin gel (source: ndc)
Generic Name repository corticotropin (source: ndc)
Application Number NDA008975 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 80 [USP'U]/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-11) / 1 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-15) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

62559-860-11 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-11) / 1 mL in 1 VIAL, MULTI-DOSE 62559-860-15 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-15) / 5 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

corticotropin (80 [USP'U]/mL)

Linked Drug Pages (1)

Purified Cortrophin Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "SUBCUTANEOUS"], "spl_id": "acbfd15f-c384-4b64-b444-33952abc3566", "openfda": {"nui": ["M0000499", "N0000175941"], "upc": ["0046211000095", "0362559860116"], "unii": ["K0U68Q2TXA"], "rxcui": ["309541", "2584475", "2685293", "2685298", "2707578", "2707580"], "spl_set_id": ["f27544ee-a0e2-4d84-b193-1c9efdf9e34c"], "pharm_class_cs": ["Adrenocorticotropic Hormone [CS]"], "pharm_class_epc": ["Adrenocorticotropic Hormone [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-11)  / 1 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "62559-860-11", "marketing_start_date": "20230814"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-15)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "62559-860-15", "marketing_start_date": "20211029"}], "brand_name": "Purified Cortrophin Gel", "product_id": "62559-860_acbfd15f-c384-4b64-b444-33952abc3566", "dosage_form": "INJECTION", "pharm_class": ["Adrenocorticotropic Hormone [CS]", "Adrenocorticotropic Hormone [EPC]"], "product_ndc": "62559-860", "generic_name": "Repository Corticotropin", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Purified Cortrophin Gel", "active_ingredients": [{"name": "CORTICOTROPIN", "strength": "80 [USP'U]/mL"}], "application_number": "NDA008975", "marketing_category": "NDA", "marketing_start_date": "20211029", "listing_expiration_date": "20271231"}