Clobetasol Propionate

Product NDC: 50383-269
Requested package NDC: 50383-269-15
11-digit product format: 503830269
Labeler code: 50383
Product ID: 50383-269_ab3ec2c7-dc10-4b1d-ab37-ff5ebfbe9b16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clobetasol Propionate
Dosage form: GEL
Route: TOPICAL
Labeler: Akorn
Application: ANDA076141
Marketing category: ANDA
Marketing start: 2010-06-07
Marketing end: 0000-00-00
Substance: CLOBETASOL PROPIONATE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	50383-269	50383-269-15	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	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`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
A076141-001	EMBELINE	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL			2002-04-12

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076141-001	EMBELINE	0.05%	GEL / TOPICAL		2002-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076141-001	EMBELINE	0.05%	GEL / TOPICAL	AB	2002-04-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076141-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076141-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076141-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076141-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076141-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076141-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076141-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076141-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076141-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076141-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076141-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076141-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076141-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076141-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076141-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076141-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076141-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076141-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076141-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076141-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076141-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076141-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076141-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076141-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076141-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076141-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
20abe2c3-3e80-d2b2-39eb-3156e4af4799	Product name	3	20250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6f	Product name	1	20250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571df	Product name	7	20250107
3813b789-94b9-edd6-f010-6b926dd462e5	Product name	5	20230113
30eee8a1-850e-41ed-b5ab-761301aeab49	Product name	6	20221206
18e5b6f7-c414-b1f1-b684-17fdd02c215e	Product name	4	20210927
1c87bbde-dd91-a122-db33-67ae814cb645	Product name	7	20210510
519b5875-7d7d-4aa6-9d3d-470fa1376595	Product name	4	20200227
98669154-3e9c-47da-8a2c-656ab71848be	Product name	2	20180607
8d4f8539-436f-453b-8b76-5322d403fc8e	Product name	1	20180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5	Product name	2	20171010

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-269-15	2024-01-30	C162847	48780-1	1030e365-5fe2-111a-e063-dadaa90a10e2	Clobetasol Propionate Gel, 0.05%
50383-269-30	2024-01-30	C162847	48780-1	1030e365-5fe2-111a-e063-dadaa90a10e2	Clobetasol Propionate Gel, 0.05%
50383-269-60	2024-01-30	C162847	48780-1	1030e365-5fe2-111a-e063-dadaa90a10e2	Clobetasol Propionate Gel, 0.05%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-269-15	GM - Gram	50383-269	c0a5d166-b858-4841-bdc3-f280a007ab39	1	2012-07-24
50383-269-30	GM - Gram	50383-269	5d3eb952-e097-462e-ba47-8520e4c3b19f	1	2012-07-24
50383-269-60	GM - Gram	50383-269	a0abd89f-120e-495c-9e6c-37cb42e5af2a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOBETASOL PROPIONATE	ACTIVE INGREDIENT	779619577M	CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.]	2
CLOBETASOL	ACTIVE MOIETY	ADN79D536H	CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.]	2
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	HHT01ZNK31	CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-269	CLOBETASOL PROPIONATE GEL [AKORN]	5	Legacy NDC	20220312_52858738-a71c-4330-a7b3-e9c6c2161e04.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
779619577M	CLOBETASOL PROPIONATE	25122-46-7	CLOBETASOL PROPIONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-269-15	50383026915	1 TUBE in 1 CARTON (50383-269-15) > 15 g in 1 TUBE	1 tube	2010-06-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobetasol Propionate Gel, 0.05%	Akorn \| Akorn Operating Company LLC	2022-03-11	HUMAN PRESCRIPTION DRUG LABEL	5