Application 088799

Type: ANDA
Sponsor: TARO PHARM INDS LTD

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A088799-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT		1984-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088799-001	AT

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088799-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088799-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088799-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088799-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088799-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088799-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088799-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088799-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088799-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088799-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088799-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088799-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088799-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088799-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088799-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088799-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088799-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088799-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088799-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088799-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088799-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088799-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088799-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088799-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088799-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088799-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088799-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088799-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088799-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088799-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088799-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088799-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088799-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088799-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088799-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088799-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088799-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088799-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088799-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088799-001	AT	1	`cb3db0bc1861…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	02ab1006-c7c8-42c9-bda8-62c9d7142521	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799
HYDROCORTISONE	HYDROCORTISONE	DIRECT RX	3d017594-3a00-40ba-b392-1699992fa1b1	2026-03-05	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799 ndc (product): 61919-364
Proctosol-HC	HYDROCORTISONE	Bryant Ranch Prepack	68e177fd-87aa-45f3-a380-0d092abdb77d	2025-11-05	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	e4f22e9c-cf38-473a-8f7d-8da7fd696f76	2025-10-02	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799 ndc (product): 51672-3003
Proctosol-HC	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	565284e7-4994-486b-8267-18bd166655ac	2025-07-02	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799 ndc (product): 10631-407
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	ac3947c9-5a66-b4e7-e053-2995a90a6f67	2024-07-17	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799 ndc (product): 68071-2233

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10631-407	Proctosol-HC	Hydrocortisone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
10631-407	Proctosol-HC	Hydrocortisone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
10631-407	Proctosol-HC	Hydrocortisone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
33261-520	Hydrocortisone	Hydrocortisone	Aidarex Pharmaceuticals LLC	ANDA	Current
50090-1549	Proctosol-HC	Hydrocortisone	A-S Medication Solutions	ANDA	Current
50436-2144	Hydrocortisone	Hydrocortisone	Unit Dose Services	ANDA	Current
51672-3003	Hydrocortisone	Hydrocortisone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-3003	Hydrocortisone	Hydrocortisone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
61919-364	HYDROCORTISONE	HYDROCORTISONE	DIRECT RX	ANDA	Current
61919-364	HYDROCORTISONE	HYDROCORTISONE	DIRECT RX	ANDA	Current
61919-364	HYDROCORTISONE	HYDROCORTISONE	DIRECT RX	ANDA	Current
68071-2233	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2233	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9715	Hydrocortisone	Hydrocortisone	Preferred Pharmaceuticals, Inc	ANDA	Current