Hydrocortisone

Product NDC: 68071-4582
Requested package NDC: 68071-4582-3
11-digit product format: 680714582
Labeler code: 68071
Product ID: 68071-4582_bbf18e2d-9131-70a5-e053-2995a90abddd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA080706
Marketing category: ANDA
Marketing start: 2016-04-01
Marketing end: 0000-00-00
Substance: HYDROCORTISONE
Active strength: 25 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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	68071-4582	68071-4582-3	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	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080706-006	ALA-CORT	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	Approved before 1982
A080706-007	ALA-CORT	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT		2016-01-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A080706-006	AT
A080706-007	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A080706-006	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080706-007	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-006	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-007	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080706-006	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080706-007	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-006	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-007	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-006	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-007	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-006	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-007	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-006	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-007	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-006	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-007	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-006	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-007	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080706-006	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080706-007	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-006	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-007	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-006	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-007	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-006	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-007	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080706-006	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080706-007	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-006	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-007	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080706-006	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080706-007	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080706-006	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080706-007	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080706-006	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080706-007	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080706-006	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080706-007	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080706-006	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080706-007	AT	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-12	Hydrocortisone Cream USP 1%, 2.5%
2023-01-30	Hydrocortisone Cream USP 1%, 2.5%
2021-02-22	Hydrocortisone Cream USP 1%, 2.5%
2021-01-29	Hydrocortisone Cream USP 1%, 2.5%

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	04758c46-0ca4-4852-acdc-1f8553ce2e6e	2026-05-21	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	026728d4-846b-4bd4-9183-ae6c4a714138	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Sportpharm LLC	78f43570-b6fd-42eb-bb9e-580abf79bf0d	2026-04-24	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	5e95eb82-40cd-411b-9006-c27b65db4b3f	2026-03-25	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	7f262fa3-4d2a-43f2-a4a7-f49f6034cf50	2026-03-25	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	3d17e73a-15f5-4881-baf2-47a0149585fd	2026-03-25	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5c4c3e02-5272-4a28-a9c8-1c5fa3ae181c	2026-01-30	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Crown Laboratories	a84830ad-73dc-4a2e-b987-0a1103526535	2026-01-12	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Alacort	HYDROCORTISONE	Crown Laboratories	de000081-a245-4f6b-9e7c-e47d84b82338	2026-01-12	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	ANI Pharmaceuticals, Inc.	b2918ac7-14b5-4372-9055-8caf6f4bcf37	2025-12-22	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	b6808d2d-192c-4d70-a2e8-bf13375c0280	2025-11-05	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706

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
68071-4582-3	68071458203	30 g in 1 BOX (68071-4582-3)	30 g	2018-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Cream USP 1%, 2.5%	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	3