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 20 of 20 · 389 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anusol HC	HYDROCORTISONE	Salix Pharmaceuticals, Inc	5a0439c8-50a0-4f85-9cb4-9e3a5b0c31e7	2023-06-01	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Asclemed USA, Inc.	459a9907-1261-4a75-8388-f0e2f466939c	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	d50240db-f630-4008-a272-55ba5c991304	2022-07-01	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Asclemed USA, Inc.	b8437441-a4a6-4fb5-82eb-e49af69704f4	2021-04-10	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Actavis Pharma, Inc.	aa9dba84-eb38-4ec3-8555-87c948bf2384	2020-07-01	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Aloe Cort	HYDROCORTISONE	Topiderm, Inc.	789a6669-3320-4558-8d6f-ab255db50d8d	2019-09-17	Warnings	Name fallback generic name: HYDROCORTISONE
Discount Drug Mart Anti-itch	HYDROCORTISONE	DISCOUNT DRUG MART, INC.	853eee29-6f57-59d4-e053-2991aa0aa611	2019-03-29	Warnings	Name fallback generic name: HYDROCORTISONE
Cortisol Phenolic	HYDROCORTISONE	Energique, Inc.	43d65eee-f4c3-4a6a-a3bb-cfa6d672bc47	2018-09-13	Warnings	Name fallback generic name: HYDROCORTISONE
Intensive Healing Eczema	HYDROCORTISONE	Walgreens	3d27f041-c554-4139-87b5-709537785f22	2018-02-04	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