Application 040646

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE	HYDROCORTISONE	TABLET;ORAL	5MG	No	No
002	HYDROCORTISONE	HYDROCORTISONE	TABLET;ORAL	10MG	No	No
003	HYDROCORTISONE	HYDROCORTISONE	TABLET;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040646-001	HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30
A040646-002	HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30
A040646-003	HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040646-001	AB
A040646-002	AB
A040646-003	AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040646-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040646-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040646-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040646-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040646-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040646-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040646-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040646-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040646-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040646-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040646-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040646-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040646-001	AB	1	`1e350fbaab3a…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCORTISONE	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	0bbb8a63-ae1d-41d7-b201-d1b171b31f46	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646
HYDROCORTISONE	HYDROCORTISONE	Major Pharmaceuticals	91885fc8-876f-4a4d-8ae5-eb246a335808	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646 ndc (product): 0904-7188
HYDROCORTISONE	HYDROCORTISONE	AvPAK	f3956208-291c-7374-e053-2a95a90a4628	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	47bfae62-bf25-413e-93fc-3c72c901f1a5	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646 ndc (product): 71335-1989
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	6c676166-2471-478c-b662-f8c9c168977b	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	134fae59-f928-4304-86ca-2271b593caf4	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646 ndc (product): 71335-2044
HYDROCORTISONE	HYDROCORTISONE	Amneal Pharmaceuticals of New York LLC	9fe627ad-4aba-4bd1-8590-6cc2d61674ba	2024-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646 ndc (product): 0115-1697 ndc (product): 0115-1700 ndc (product): 0115-1696

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1696	HYDROCORTISONE	hydrocortisone	Impax Generics	ANDA	Current
0115-1696	HYDROCORTISONE	hydrocortisone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1696	HYDROCORTISONE	hydrocortisone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1697	HYDROCORTISONE	hydrocortisone	Impax Generics	ANDA	Current
0115-1697	HYDROCORTISONE	hydrocortisone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1697	HYDROCORTISONE	hydrocortisone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1700	HYDROCORTISONE	hydrocortisone	Impax Generics	ANDA	Current
0115-1700	HYDROCORTISONE	hydrocortisone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1700	HYDROCORTISONE	hydrocortisone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0904-7188	HYDROCORTISONE	hydrocortisone	Major Pharmaceuticals	ANDA	Current
54505-331	HYDROCORTISONE	hydrocortisone	Lineage Therapeutics Inc	ANDA	Current
54505-332	HYDROCORTISONE	hydrocortisone	Lineage Therapeutics Inc	ANDA	Current
54505-333	HYDROCORTISONE	hydrocortisone	Lineage Therapeutics Inc	ANDA	Current
63629-7241	HYDROCORTISONE	hydrocortisone	Bryant Ranch Prepack	ANDA	Current
68151-2269	HYDROCORTISONE	hydrocortisone	Carilion Materials Management	ANDA	Current
71335-1989	HYDROCORTISONE	hydrocortisone	Bryant Ranch Prepack	ANDA	Current
71335-2044	HYDROCORTISONE	hydrocortisone	Bryant Ranch Prepack	ANDA	Current
71335-2044	HYDROCORTISONE	hydrocortisone	Bryant Ranch Prepack	ANDA	Current