Home NDC 62559-860 Purified Cortrophin Gel
Product NDC 62559-860
11-digit product format 625590860
Labeler code 62559
Product ID 62559-860_acbfd15f-c384-4b64-b444-33952abc3566
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Repository Corticotropin
Dosage form INJECTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler ANI Pharmaceuticals, Inc.
Application NDA008975
Marketing category NDA
Marketing start 2021-10-29
Substance CORTICOTROPIN
Active strength 80 [USP'U]/mL
Pharmacologic classes Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N008975-001 PURIFIED CORTROPHIN GEL CORTICOTROPIN 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 N008975-002 PURIFIED CORTROPHIN GEL CORTICOTROPIN 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982
Orange Book patents# Current patent rows page 1 of 2 · 116 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N008975-001 PURIFIED CORTROPHIN GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N008975-002 PURIFIED CORTROPHIN GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 28 · 1,086 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Purified Cortrophin Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CORTICOTROPIN 80 [USP'U]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K0U68Q2TXA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309541 Internal RxNorm lookup 2584475 Internal RxNorm lookup 2685293 Internal RxNorm lookup 2685298 Internal RxNorm lookup 2707578 Internal RxNorm lookup 2707580 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62559-860-11 Purified Cortrophin Gel 1 in 1 CARTON INJECTION 1 14 62559-860-11 Purified Cortrophin Gel 1 mL in 1 VIAL, MULTI-DOSE INJECTION 1 14 62559-860-15 Purified Cortrophin Gel 1 in 1 CARTON INJECTION 1 14 62559-860-15 Purified Cortrophin Gel 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-860 PURIFIED CORTROPHIN GEL (REPOSITORY CORTICOTROPIN) INJECTION [ANI PHARMACEUTICALS, INC.] 12 Current NDC, Legacy NDC, 4 package rows 20250308_f27544ee-a0e2-4d84-b193-1c9efdf9e34c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 62559-860-11 62559086011 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-11) / 1 mL in 1 VIAL, MULTI-DOSE 2023-08-14 No No Current 62559-860-15 62559086015 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-15) / 5 mL in 1 VIAL, MULTI-DOSE 2021-10-29 0000-00-00 No No Current