Purified Cortrophin Gel

Product NDC: 62559-861
11-digit product format: 625590861
Labeler code: 62559
Product ID: 62559-861_acbfd15f-c384-4b64-b444-33952abc3566
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Repository Corticotropin
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: ANI Pharmaceuticals, Inc.
Application: NDA008975
Marketing category: NDA
Marketing start: 2025-02-28
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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N008975-001	12102662	2043-10-27	U-3904	2024-10-04
N008975-001	12102662	2043-10-27	U-3905	2024-10-04
N008975-001	12102662	2043-10-27	U-3906	2024-10-04
N008975-001	12102662	2043-10-27	U-3907	2024-10-04
N008975-001	12102662	2043-10-27	U-3908	2024-10-04
N008975-001	12102662	2043-10-27	U-3909	2024-10-04
N008975-001	12102662	2043-10-27	U-3910	2024-10-04
N008975-001	12102662	2043-10-27	U-3911	2024-10-04
N008975-001	12102662	2043-10-27	U-3912	2024-10-04
N008975-001	12102662	2043-10-27	U-3913	2024-10-04
N008975-001	12102662	2043-10-27	U-3914	2024-10-04
N008975-001	12102662	2043-10-27	U-3915	2024-10-04
N008975-001	12102662	2043-10-27	U-3916	2024-10-04
N008975-001	12102662	2043-10-27	U-3917	2024-10-04
N008975-001	12102662	2043-10-27	U-3918	2024-10-04
N008975-001	12102662	2043-10-27	U-3919	2024-10-04
N008975-001	12102662	2043-10-27	U-3920	2024-10-04
N008975-001	12102662	2043-10-27	U-3921	2024-10-04
N008975-001	12102662	2043-10-27	U-3922	2024-10-04
N008975-001	12102662	2043-10-27	U-3923	2024-10-04
N008975-001	12102662	2043-10-27	U-3924	2024-10-04
N008975-001	12102662	2043-10-27	U-3925	2024-10-04
N008975-001	12102662	2043-10-27	U-3926	2024-10-04
N008975-002	11975047	2043-10-27	U-3904	2024-05-17
N008975-002	11975047	2043-10-27	U-3905	2024-05-17
N008975-002	11975047	2043-10-27	U-3906	2024-05-17
N008975-002	11975047	2043-10-27	U-3907	2024-05-17
N008975-002	11975047	2043-10-27	U-3908	2024-05-17
N008975-002	11975047	2043-10-27	U-3909	2024-05-17
N008975-002	11975047	2043-10-27	U-3910	2024-05-17
N008975-002	11975047	2043-10-27	U-3911	2024-05-17
N008975-002	11975047	2043-10-27	U-3912	2024-05-17
N008975-002	11975047	2043-10-27	U-3913	2024-05-17
N008975-002	11975047	2043-10-27	U-3914	2024-05-17
N008975-002	11975047	2043-10-27	U-3915	2024-05-17
N008975-002	11975047	2043-10-27	U-3916	2024-05-17
N008975-002	11975047	2043-10-27	U-3917	2024-05-17
N008975-002	11975047	2043-10-27	U-3918	2024-05-17
N008975-002	11975047	2043-10-27	U-3919	2024-05-17
N008975-002	11975047	2043-10-27	U-3920	2024-05-17
N008975-002	11975047	2043-10-27	U-3921	2024-05-17
N008975-002	11975047	2043-10-27	U-3922	2024-05-17
N008975-002	11975047	2043-10-27	U-3923	2024-05-17
N008975-002	11975047	2043-10-27	U-3924	2024-05-17
N008975-002	11975047	2043-10-27	U-3925	2024-05-17
N008975-002	11975047	2043-10-27	U-3926	2024-05-17
N008975-002	12102662	2043-10-27	U-3904	2024-10-04
N008975-002	12102662	2043-10-27	U-3905	2024-10-04
N008975-002	12102662	2043-10-27	U-3906	2024-10-04
N008975-002	12102662	2043-10-27	U-3907	2024-10-04
N008975-002	12102662	2043-10-27	U-3908	2024-10-04
N008975-002	12102662	2043-10-27	U-3909	2024-10-04
N008975-002	12102662	2043-10-27	U-3910	2024-10-04
N008975-002	12102662	2043-10-27	U-3911	2024-10-04
N008975-002	12102662	2043-10-27	U-3912	2024-10-04
N008975-002	12102662	2043-10-27	U-3913	2024-10-04
N008975-002	12102662	2043-10-27	U-3914	2024-10-04
N008975-002	12102662	2043-10-27	U-3915	2024-10-04
N008975-002	12102662	2043-10-27	U-3916	2024-10-04
N008975-002	12102662	2043-10-27	U-3917	2024-10-04
N008975-002	12102662	2043-10-27	U-3918	2024-10-04
N008975-002	12102662	2043-10-27	U-3919	2024-10-04
N008975-002	12102662	2043-10-27	U-3920	2024-10-04
N008975-002	12102662	2043-10-27	U-3921	2024-10-04
N008975-002	12102662	2043-10-27	U-3922	2024-10-04
N008975-002	12102662	2043-10-27	U-3923	2024-10-04
N008975-002	12102662	2043-10-27	U-3924	2024-10-04
N008975-002	12102662	2043-10-27	U-3925	2024-10-04
N008975-002	12102662	2043-10-27	U-3926	2024-10-04
N008975-002	12233105	2043-10-27	U-3904	2025-03-05
N008975-002	12233105	2043-10-27	U-3905	2025-03-05
N008975-002	12233105	2043-10-27	U-3906	2025-03-05
N008975-002	12233105	2043-10-27	U-3907	2025-03-05
N008975-002	12233105	2043-10-27	U-3908	2025-03-05
N008975-002	12233105	2043-10-27	U-3909	2025-03-05
N008975-002	12233105	2043-10-27	U-3910	2025-03-05
N008975-002	12233105	2043-10-27	U-3911	2025-03-05
N008975-002	12233105	2043-10-27	U-3912	2025-03-05
N008975-002	12233105	2043-10-27	U-3913	2025-03-05
N008975-002	12233105	2043-10-27	U-3914	2025-03-05

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	RLD / RS	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3917	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3918	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3919	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3920	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3921	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3922	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3923	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3924	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3925	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3926	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3904	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3905	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3906	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3907	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3908	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3909	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3910	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3911	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3912	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3913	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3914	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3915	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3916	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3904	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3905	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3906	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3907	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3908	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3909	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3910	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3911	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3912	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3913	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3914	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3915	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3916	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3917	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3918	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3919	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3920	2024-05-17	`caaa826d4ba7…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f27544ee-a0e2-4d84-b193-1c9efdf9e34c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7314d8f7-fa99-4dc2-9f68-de2ff142f4b7	Product name	2	20250121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62559-861-11	Purified Cortrophin Gel	1 mL in 1 SYRINGE, GLASS	INJECTION	1	14
62559-861-11	Purified Cortrophin Gel	1 in 1 CARTON	INJECTION	1	14
62559-861-35	Purified Cortrophin Gel	0.5 mL in 1 SYRINGE, GLASS	INJECTION	0.5	14
62559-861-35	Purified Cortrophin Gel	1 in 1 CARTON	INJECTION	1	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-861-11	ML - Milliliter	62559-861	137cc9a4-aa31-4e98-a257-3a12dba0349d	1	2025-05-14
62559-861-35	ML - Milliliter	62559-861	d7e7ce7c-51bc-43ee-abae-d1581d216b90	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-861	PURIFIED CORTROPHIN GEL (REPOSITORY CORTICOTROPIN) INJECTION [ANI PHARMACEUTICALS, INC.]	12	Current 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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Purified Cortrophin Gel	REPOSITORY CORTICOTROPIN	ANI Pharmaceuticals, Inc.	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008975 application number: NDA008975 ndc (product): 62559-861

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K0U68Q2TXA	CORTICOTROPIN	12427-33-7	CORTICOTROPIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2685298	corticotropin 40 UNT in 0.5 ML Prefilled Self-Controlled Injector	PSN	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2685293	corticotropin 80 UNT in 1 ML Prefilled Self-Controlled Injector	PSN	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
309541	corticotropin 80 UNT/ML Injectable Solution	PSN	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2707580	Cortrophin 40 UNT in 0.5 ML Prefilled Syringe	PSN	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2707578	Cortrophin 80 UNT in 1 ML Prefilled Syringe	PSN	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2584475	CORTROPHIN 80 UNT/ML Injectable Solution	PSN	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2707580	0.5 ML corticotropin 80 UNT/ML Prefilled Syringe [Cortrophin]	SBD	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2707578	1 ML corticotropin 80 UNT/ML Prefilled Syringe [Cortrophin]	SBD	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2584475	corticotropin 80 UNT/ML Injectable Solution [Cortrophin]	SBD	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2685298	0.5 ML corticotropin 80 UNT/ML Prefilled Syringe	SCD	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2685293	1 ML corticotropin 80 UNT/ML Prefilled Syringe	SCD	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
309541	corticotropin 80 UNT/ML Injectable Solution	SCD	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2685298	corticotropin 40 UNT per 0.5 ML Prefilled Self-Controlled Injector	SY	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
309541	corticotropin 400 UNT per 5 ML Injectable Solution	SY	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2685293	corticotropin 80 UNT per 1 ML Prefilled Self-Controlled Injector	SY	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2707580	Cortrophin 40 UNT per 0.5 ML Prefilled Syringe	SY	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2584475	Cortrophin 400 UNT per 5 ML Injectable Solution	SY	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2707578	Cortrophin 80 UNT per 1 ML Prefilled Syringe	SY	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14
2584475	Cortrophin 80 UNT/ML Injectable Solution	SY	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
62559-861-11	62559086111	1 SYRINGE, GLASS in 1 CARTON (62559-861-11) / 1 mL in 1 SYRINGE, GLASS	2025-02-28	No	No	Current
62559-861-35	62559086135	1 SYRINGE, GLASS in 1 CARTON (62559-861-35) / .5 mL in 1 SYRINGE, GLASS	2025-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PURIFIED CORTROPHIN ® GEL (Repository Corticotropin Injection USP) Rx only	ANI Pharmaceuticals, Inc.	2026-02-09	HUMAN PRESCRIPTION DRUG LABEL	14