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 3 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Scalpicin Anti-Itch Maximum Strength	HYDROCORTISONE	Reckitt Benckiser LLC	7b1a29fa-b266-43e6-a87b-aa3c96ab4041	2026-05-13	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	02ab1006-c7c8-42c9-bda8-62c9d7142521	2026-05-11	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	058bb2ff-ff51-4a3b-ba47-cb02272d0631	2026-05-11	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	12cd35e3-e707-4551-b778-bf615c1a8d32	2026-05-11	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	0bbb8a63-ae1d-41d7-b201-d1b171b31f46	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	026728d4-846b-4bd4-9183-ae6c4a714138	2026-05-11	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Harris Teeter Hydrocortisone	HYDROCORTISONE	HARRIS TEETER LLC	4e8199f8-96ec-5342-e063-6294a90afb2d	2026-05-07	Warnings	Name fallback generic name: HYDROCORTISONE
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc.	5114cdba-96a1-c399-e063-6294a90aac12	2026-05-06	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	2dc7f76f-f9ad-46ba-8b41-952e1c15f052	2026-04-29	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
anti itch	HYDROCORTISONE	HyVee Inc	e1db3641-2e83-4fec-8394-98d0d876ce0d	2026-04-29	Warnings	Name fallback generic name: HYDROCORTISONE
FixMySkin Healing Balm Vanilla Flavor	HYDROCORTISONE	Lovely Skin, Inc.	52f7a561-a0b5-4562-a588-d74fd874b83a	2026-04-28	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Sportpharm LLC	ef9cf62a-5805-48bc-915e-c0e91a10837e	2026-04-24	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Sportpharm LLC	78f43570-b6fd-42eb-bb9e-580abf79bf0d	2026-04-24	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
FixMySkin Healing Balm Unflavored	HYDROCORTISONE	Lovely Skin, Inc.	9ff8db07-ad6d-4865-a534-94bd8312957e	2026-04-23	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	c3916e9f-f783-45a2-b38b-959b12c26252	2026-04-22	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone 1%	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4	2026-04-22	Warnings	Name fallback generic name: HYDROCORTISONE
Alkindi Sprinkle	HYDROCORTISONE	Eton Pharmaceuticals, Inc.	26c13a5f-7119-4c6a-bf10-fda4e07d7682	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Anti-Itch Regular Strength	HYDROCORTISONE	CVS Pharmacy	9fe7768b-9023-c9ee-e053-2a95a90a55b3	2026-04-17	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE CREAM	HART Health	c76fb030-cbb5-4773-aa52-d038cb41d0af	2026-04-15	Warnings	Name fallback brand name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	2352bb58-a624-4c5e-8966-f68817c30470	2026-04-03	Adverse reactions	Name fallback brand name: Hydrocortisone 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