Purified Cortrophin Gel

Product NDC: 62559-860
11-digit product format: 625590860
Labeler code: 62559
Product ID: 62559-860_05d1d8ab-30b0-4d58-9f46-8c3b4bc82cc0
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 44.

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 · 122 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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`84e616aacf4f…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 34 · 1,324 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3917	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3918	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3919	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3920	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3921	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3922	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3923	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3924	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3925	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3926	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3904	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3905	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3906	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3907	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3908	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3909	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3910	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3911	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3912	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3913	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3914	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3915	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3916	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3904	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3905	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3906	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3907	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3908	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3909	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3910	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3911	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3912	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3913	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3914	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3915	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3916	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3917	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3918	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3919	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3920	2024-05-17	`c2088c7a36db…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

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
62559-860-11	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-860-11	ML - Milliliter	62559-860	dfb34cc1-d74a-4217-a821-c22fea7da9b4	1	2023-08-08
62559-860-15	ML - Milliliter	62559-860	3d35b6b2-839e-4a03-b159-77ba7bbcd0a7	1	2022-01-06

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

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	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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PURIFIED CORTROPHIN ® GEL (Repository Corticotropin Injection USP) Rx only	ANI Pharmaceuticals, Inc.	2026-10-05	HUMAN PRESCRIPTION DRUG LABEL	15