Application 040761

Type: ANDA
Sponsor: VINTAGE

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 43.

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	Approval date
A040761-001	HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16
A040761-002	HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16
A040761-003	HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040761-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040761-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040761-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A040761-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040761-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040761-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040761-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040761-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040761-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040761-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040761-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040761-003	AB	1	`ea99ee380514…`

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 12 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	2ada9ec2-1c28-4da2-8639-07b3193ffb32	2025-07-03	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone with Aloe	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	caa2fd64-e262-4d7c-ad8a-69f506feba8c	2025-07-03	Warnings	Name fallback generic name: HYDROCORTISONE
Proctosol-HC	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	565284e7-4994-486b-8267-18bd166655ac	2025-07-02	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Water Resistant	HYDROCORTISONE	Chattem, Inc.	118e55e7-241f-44c4-959e-09bf6221bd77	2025-07-01	Warnings	Name fallback generic name: HYDROCORTISONE
MediBalm	HYDROCORTISONE	BalmRx, LLC	324dd151-84c5-3e2f-e063-6394a90a569d	2025-06-26	Warnings	Name fallback generic name: HYDROCORTISONE
Post-Treatment Repair Cream	HYDROCORTISONE	Vi Medical Products Inc.	ab8885a9-0778-28ff-e053-2995a90a2e12	2025-06-19	Warnings	Name fallback generic name: HYDROCORTISONE
ProCure Hydrocortisone 1%	HYDROCORTISONE	Twin Med LLC	37cdfabc-1fdb-246a-e063-6394a90a008a	2025-06-17	Warnings	Name fallback generic name: HYDROCORTISONE
ProCure Hydrocortisone 1%	HYDROCORTISONE	Twin Med LLC	37ce6c35-b211-43de-e063-6294a90ab773	2025-06-17	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	f7aecfb4-c194-4554-8d05-4e46005e654b	2025-05-27	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	d57a59fb-c8f2-f73b-e053-2995a90a4cdb	2025-05-08	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	4c96ec41-841c-322b-e054-00144ff8d46c	2025-05-08	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	ANI Pharmaceuticals, Inc.	0d7e8e04-9149-4436-bad1-b700e253b7ab	2025-05-05	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	A2A Integrated Pharmaceuticals, LLC	31431866-6fb5-2acd-e063-6294a90ac520	2025-03-31	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
DermaCort Anti-itch	HYDROCORTISONE	Melaleuca, Inc.	24044b0f-dd1e-4762-82b8-7a28b08c2f77	2025-03-20	Warnings	Name fallback generic name: HYDROCORTISONE
Post Treatment Repair Cream	HYDROCORTISONE	Vege Labs LLC.	302d4327-354b-a252-e063-6394a90a20b6	2025-03-12	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Walgreens Co.	c22bba5c-bb6f-494e-987a-f6e36c1b4893	2025-03-06	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Thera Plus Hydrocortisone Maximum Strength	HYDROCORTISONE	FOURSTAR GROUP USA, INC.	c2bc8f0c-38ea-4124-bc51-bf22e6751a92	2025-03-04	Warnings	Name fallback generic name: HYDROCORTISONE
Thera Plus Eczema Hydrocortisone Anti Itch	HYDROCORTISONE	Fourstar Group USA, Inc.	7c72217b-db9a-4573-9f14-4c11528fa452	2025-03-04	Warnings	Name fallback generic name: HYDROCORTISONE
Thera Plus Maximum Strength Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc.	fb89dca6-c0c0-4092-b3f5-e59c956c3d6c	2025-03-04	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone with aloe	HYDROCORTISONE	Encube Ethicals, Inc.	12a1774d-a97e-4787-b6b1-8e8cd40b7b70	2025-02-26	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-3899	Hydrocortisone	hydrocortisone	Par Pharmaceutical	ANDA	Current
0603-3900	Hydrocortisone	hydrocortisone	Par Pharmaceutical	ANDA	Current
0603-3901	Hydrocortisone	hydrocortisone	Par Pharmaceutical	ANDA	Current
43063-208	Hydrocortisone	hydrocortisone	PD-Rx Pharmaceuticals, In	ANDA	Current
68084-469	Hydrocortisone	hydrocortisone	American Health Packaging	ANDA	Current
68084-789	Hydrocortisone	hydrocortisone	American Health Packaging	ANDA	Current
68084-930	Hydrocortisone	hydrocortisone	American Health Packaging	ANDA	Current
68151-4021	Hydrocortisone	hydrocortisone	Carilion Materials Management	ANDA	Current