Application 085025

Type: ANDA
Sponsor: PERRIGO NEW YORK

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
A085025-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A085025-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`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	A085025-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085025-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085025-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085025-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085025-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085025-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085025-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085025-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085025-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085025-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085025-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085025-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085025-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085025-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085025-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085025-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085025-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085025-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085025-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085025-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085025-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085025-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085025-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085025-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085025-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085025-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085025-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085025-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085025-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085025-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085025-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085025-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085025-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085025-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085025-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085025-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085025-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085025-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085025-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085025-001	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	058bb2ff-ff51-4a3b-ba47-cb02272d0631	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025 ndc (product): 68788-9922
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	2352bb58-a624-4c5e-8966-f68817c30470	2026-04-03	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	REMEDYREPACK INC.	f0e66726-946b-4f63-b457-2851dc69e6b4	2026-04-03	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025 ndc (product): 70518-3078
Hydrocortisone Cream	HYDROCORTISONE CREAM	Direct_Rx	19b09776-165a-9579-e063-6294a90a9d39	2026-03-05	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Procto-Med HC	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	4b972547-5bd4-155d-e063-6394a90a03ee	2026-03-02	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	bb959c6f-7c9a-43c5-a45b-2ad9a87baa88	2026-02-18	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025 ndc (product): 50090-0350
Hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	7ba59aa6-b828-4048-bf86-90c90d9894a0	2026-01-06	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025 ndc (product): 45802-004
Procto-Med HC	HYDROCORTISONE	Leading Pharma, LLC	0682580e-aff8-4b67-99ba-a29ab7b433db	2026-01-06	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025 ndc (product): 69315-312
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5d7ae83f-e9ad-4805-812c-919065cb69af	2024-10-02	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025 ndc (product): 50090-0244
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	84c95149-9064-4b4d-a7d0-93dfefca1370	2024-08-22	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025 ndc (product): 63629-8666
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	5bb279c6-d572-43a2-e053-2991aa0a686e	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025 ndc (product): 66267-967
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	e1166b3a-a304-4030-ab51-eb55c6e91afd	2024-08-01	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	b33f51f5-7506-43d3-863b-406dc5c7d167	2023-07-18	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025 ndc (product): 63629-8667

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42254-164	Hydrocortisone	Hydrocortisone	Rebel Distributors Corp	ANDA	Current
45802-004	Hydrocortisone	Hydrocortisone	Perrigo New York Inc	ANDA	Current
45802-004	Hydrocortisone	Hydrocortisone	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
50090-0244	Hydrocortisone	Hydrocortisone	A-S Medication Solutions	ANDA	Current
50090-0244	Hydrocortisone	Hydrocortisone	A-S Medication Solutions	ANDA	Current
50090-0350	Hydrocortisone	Hydrocortisone	A-S Medication Solutions	ANDA	Current
50090-0350	Hydrocortisone	Hydrocortisone	A-S Medication Solutions	ANDA	Current
53002-9661	Hydrocortisone	Hydrocortisone	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9661	Hydrocortisone	Hydrocortisone	RPK Pharmaceuticals, Inc.	ANDA	Current
53217-197	Hydrocortisone	Hydrocortisone	Aidarex Pharmaceuticals LLC	ANDA	Current
55700-321	Hydrocortisone	Hydrocortisone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-321	Hydrocortisone	Hydrocortisone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-321	Hydrocortisone	Hydrocortisone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-321	Hydrocortisone	Hydrocortisone	Quality Care Products LLC	ANDA	Current
63629-8666	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-8666	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-8666	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-8667	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-8667	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-8667	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
66267-967	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-967	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-967	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-967	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2261	Procto-Med HC	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2261	Procto-Med HC	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2546	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9922	Hydrocortisone	Hydrocortisone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9922	Hydrocortisone	Hydrocortisone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9922	Hydrocortisone	Hydrocortisone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9922	Hydrocortisone	Hydrocortisone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9922	Hydrocortisone	Hydrocortisone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9922	Hydrocortisone	Hydrocortisone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9922	Hydrocortisone	Hydrocortisone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9922	Hydrocortisone	Hydrocortisone	Preferred Pharmaceuticals, Inc.	ANDA	Current
69315-312	Procto-Med HC	HYDROCORTISONE	Leading Pharma, LLC	ANDA	Current
69315-312	Procto-Med HC	HYDROCORTISONE	LEADING PHARMA, LLC	ANDA	Current
70518-3078	Hydrocortisone	Hydrocortisone	REMEDYREPACK INC.	ANDA	Current
70518-3078	Hydrocortisone	Hydrocortisone	REMEDYREPACK INC.	ANDA	Current
70518-3078	Hydrocortisone	Hydrocortisone	REMEDYREPACK INC.	ANDA	Current
76413-160	Hydrocortisone	Hydrocortisone	Central Texas Community Health Centers	ANDA	Current