Hydrocortisone

Product NDC: 55700-321
Requested package NDC: 55700-321-30
11-digit product format: 557000321
Labeler code: 55700
Product ID: 55700-321_b738fb58-3fb9-45c2-b49d-e38d4189c312
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Quality Care Products LLC
Application: ANDA085025
Marketing category: ANDA
Marketing start: 2006-03-31
Marketing end: 0000-00-00
Substance: HYDROCORTISONE
Active strength: 25 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55700-321	55700-321-30	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55700-321-30	2025-01-08	C162847	48780-1	1030e365-047b-111a-e063-dadaa90a10e2	HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%
55700-321-30	2024-01-30	C162847	48780-1	1030e365-047b-111a-e063-dadaa90a10e2	HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-321-30	GM - Gram	55700-321	4c5fd24c-e15a-4f9b-8f8c-bf32c5dc6578	1	2016-03-04

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
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
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
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
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
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
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	84c95149-9064-4b4d-a7d0-93dfefca1370	2024-08-22	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	5bb279c6-d572-43a2-e053-2991aa0a686e	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-321-30	55700032130	28 g in 1 TUBE (55700-321-30)	28 g	2006-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Quality Care Products LLC	2022-04-21	HUMAN PRESCRIPTION DRUG LABEL	5