Hydrocortisone Acetate Cream

Product NDC: 28595-050
Requested package NDC: 28595-050-01
11-digit product format: 285950050
Labeler code: 28595
Product ID: 28595-050_57c6aacb-c134-6eb0-e063-6294a90aaefe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone Acetate Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: Allegis Pharmaceuticals, Inc.
Application: ANDA040396
Marketing category: ANDA
Marketing start: 2026-07-29
Substance: HYDROCORTISONE ACETATE
Active strength: 20 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A040396-001	MICORT-HC	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL			2001-02-27

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocortisone Acetate Cream
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE ACETATE	20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3X7931PO74	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57c6aadb-fa88-044f-e063-6394a90a3db8	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone Acetate Cream	HYDROCORTISONE ACETATE CREAM	Allegis Pharmaceuticals, Inc.	57c6aadb-fa88-044f-e063-6394a90a3db8	2026-07-29	Adverse reactions	Exact identifier application applno (ANDA): 040396 application number: ANDA040396 ndc (package): 28595-050-01 ndc (product): 28595-050 ndc11 (package): 28595005001
Hydrocortisone Acetate Cream	HYDROCORTISONE ACETATE CREAM	Allegis Holdings LLC	3b008546-afa5-fe5a-e063-6394a90adb3b	2025-07-28	Adverse reactions	Exact identifier application applno (ANDA): 040396 application number: ANDA040396

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X7931PO74	HYDROCORTISONE ACETATE	50-03-3	HYDROCORTISONE ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
28595-050-01	28595005001	28.4 g in 1 CARTON (28595-050-01)	28.4 g	2026-07-29	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone acetate Cream USP 2.5%	Allegis Pharmaceuticals, Inc.	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	1