Application 089682

Type: ANDA
Sponsor: ACTAVIS MID ATLANTIC

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 42.

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
A089682-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM / TOPICAL			1988-03-10

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 · 42 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
2026-08-18 06:07:40	2026-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL		1988-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089682-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089682-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089682-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089682-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089682-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089682-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089682-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089682-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089682-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089682-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089682-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089682-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089682-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089682-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089682-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089682-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089682-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089682-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089682-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089682-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089682-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089682-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089682-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089682-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089682-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089682-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089682-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089682-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089682-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089682-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089682-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089682-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089682-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089682-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089682-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089682-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089682-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089682-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089682-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089682-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	720357e2-6f01-737d-e053-2a95a90ae54b	2024-06-10	Adverse reactions	Exact identifier application applno (ANDA): 089682 application number: ANDA089682 ndc (product): 68071-4511
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5ee2f62a-d8d5-4efd-bf6f-f79c10855631	2023-11-22	Adverse reactions	Exact identifier application applno (ANDA): 089682 application number: ANDA089682 ndc (product): 50090-5999
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	d50240db-f630-4008-a272-55ba5c991304	2022-07-01	Adverse reactions	Exact identifier application applno (ANDA): 089682 application number: ANDA089682 ndc (product): 63187-480

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0472-0337	Hydrocortisone	Hydrocortisone	Actavis Pharma, Inc.	ANDA	Current
0472-0337	Hydrocortisone	Hydrocortisone	Actavis Pharma, Inc.	ANDA	Current
0472-0337	Hydrocortisone	Hydrocortisone	Actavis Pharma, Inc.	ANDA	Current
50090-2621	Hydrocortisone	Hydrocortisone	A-S Medication Solutions	ANDA	Current
50090-2621	Hydrocortisone	Hydrocortisone	A-S Medication Solutions	ANDA	Current
50090-2931	Procto-Med HC	HYDROCORTISONE	A-S Medication Solutions	ANDA	Current
50090-2931	Procto-Med HC	HYDROCORTISONE	A-S Medication Solutions	ANDA	Current
50090-5999	Hydrocortisone	Hydrocortisone	A-S Medication Solutions	ANDA	Current
53002-9660	Hydrocortisone	Hydrocortisone	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9660	Hydrocortisone	Hydrocortisone	RPK Pharmaceuticals, Inc.	ANDA	Current
63187-480	Hydrocortisone	Hydrocortisone	Proficient Rx LP	ANDA	Current
63187-480	Hydrocortisone	Hydrocortisone	Proficient Rx LP	ANDA	Current
63187-480	Hydrocortisone	Hydrocortisone	Proficient Rx LP	ANDA	Current
63187-480	Hydrocortisone	Hydrocortisone	Proficient Rx LP	ANDA	Current
63187-480	Hydrocortisone	Hydrocortisone	Proficient Rx LP	ANDA	Current
64980-301	Proctozone	hydrocortisone	Rising Pharmaceuticals, Inc.	ANDA	Current
66267-966	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-966	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3333	Procto-Med HC	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4511	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4511	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4878	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4878	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
69315-302	Procto-Med HC	HYDROCORTISONE	Leading Pharma, LLC	ANDA	Current
70518-0143	Hydrocortisone	Hydrocortisone	REMEDYREPACK INC.	ANDA	Current
70518-0143	Hydrocortisone	Hydrocortisone	REMEDYREPACK INC.	ANDA	Current
70518-0143	Hydrocortisone	Hydrocortisone	REMEDYREPACK INC.	ANDA	Current