Application 040310

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE	HYDROCORTISONE	OINTMENT;TOPICAL	2.5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040310-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL			2000-12-29

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 2 · 43 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	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`f41ea6bd6efb…`

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 16 of 20 · 389 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5d7ae83f-e9ad-4805-812c-919065cb69af	2024-10-02	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Herb Street Anti-Itch Stick	HYDROCORTISONE	Balassa Laboratories Inc.	8717faae-59c3-4c6f-9ef1-285c0d2445ed	2024-10-01	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Kroger Company	68dab606-0385-48b7-9a7b-a2cf83d20393	2024-09-29	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
kirkland signature hydrocortisone plus maximum strength	HYDROCORTISONE	Costco Wholesale Company	481341c5-db1f-43fb-aed7-f40495a4eab8	2024-09-29	Warnings	Name fallback generic name: HYDROCORTISONE
Care One hydrocortisone maximum strength	HYDROCORTISONE	American Sales Company	32593229-d0ac-4d6c-831a-089fc6e76152	2024-09-29	Warnings	Name fallback generic name: HYDROCORTISONE
good sense anti itch	HYDROCORTISONE	L. Perrigo Company	b7a896cc-1d78-45c0-a73e-aa1e117f7d3b	2024-09-29	Warnings	Name fallback generic name: HYDROCORTISONE
Topcare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	b7362f21-f1a3-4edc-b5b6-a16680e05df3	2024-09-29	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	H E B	412ca2d1-064b-4438-aee1-fcb5cf27c7db	2024-09-29	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
good sense anti itch	HYDROCORTISONE	A-S Medication Solutions	072dd455-24a5-4a44-aaef-d3e137d005a6	2024-09-26	Warnings	Name fallback generic name: HYDROCORTISONE
AOSI HEALTHCARE	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	f4db90ad-dd62-44f1-9655-2614ed36581e	2024-09-25	Warnings	Name fallback generic name: HYDROCORTISONE
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	83cd9f60-a4c4-4dea-97a7-cd96aade9e88	2024-09-24	Warnings	Name fallback generic name: HYDROCORTISONE
Signature Care Anti Itch	HYDROCORTISONE	Safeway	ed0eb068-3ce6-423d-a7f8-c3456b7f6040	2024-09-23	Warnings	Name fallback generic name: HYDROCORTISONE
members mark hydrocortisone	HYDROCORTISONE	Sam's West Inc	218f0dcd-fa67-4935-8019-ecbbd53ed2f7	2024-09-23	Warnings	Name fallback generic name: HYDROCORTISONE
anti itch	HYDROCORTISONE	Meijer, Inc.	a07496e0-6fc2-4190-8a01-f513134ffb92	2024-09-23	Warnings	Name fallback generic name: HYDROCORTISONE
Exchange Select Hydrocortisone	HYDROCORTISONE	Army & Air Force Exchange Service	1b709db3-7dc1-4756-a8a0-dddda875dc57	2024-09-19	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	0ae1ba79-3992-4910-b03f-6f9b0f26e300	2024-09-12	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Itch and Rash Cream	HYDROCORTISONE	Wildman Business Group	1f95757d-a434-f02a-e063-6294a90a2d12	2024-09-01	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	84c95149-9064-4b4d-a7d0-93dfefca1370	2024-08-22	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
CVS Health Maximum Strength Scalp Relief Anti-itch	HYDROCORTISONE	CVS Health	b5ef0005-8b76-4205-8be0-db3a7ed7d1c4	2024-08-19	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	5bb279c6-d572-43a2-e053-2991aa0a686e	2024-08-14	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
17768	ORIG	2004-06-07
42615	ORIG	2003-07-31
7619	ORIG	2000-12-29