Clobetasol Propionate

Product NDC: 50383-978
11-digit product format: 503830978
Labeler code: 50383
Product ID: 50383-978_ba0e75dd-33b5-40b8-97d0-0194fed2bc99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clobetasol Propionate
Dosage form: LOTION
Route: TOPICAL
Labeler: Akorn
Application: ANDA211348
Marketing category: ANDA
Marketing start: 2018-11-05
Marketing end: 0000-00-00
Substance: CLOBETASOL PROPIONATE
Active strength: 0 g/100mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50383-978		I	Inactivated by FDA	2026-08-03
excluded package	package	50383-978	50383-978-02	I	Inactivated by FDA	2026-08-03
excluded package	package	50383-978	50383-978-04	I	Inactivated by FDA	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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-978-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-978-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-978-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-978-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-978-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-978-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-978-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-978-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-978-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-978-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-978-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-978-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-978-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-978-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-978-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-978-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-978-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-978-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-978-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-978-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-978-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-978-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-978-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-978-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50383-978-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50383-978-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50383-978-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50383-978-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50383-978-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50383-978-02	`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
A211348-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL			2018-10-26

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	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2018-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211348-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2018-10-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A211348-001	AB	1	`ea99ee380514…`

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
50383-978-02	2024-01-30	C162847	48780-1	1030e365-1eef-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE LOTION safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE LOTION. CLOBETASOL PROPIONATE lotion, for topical use Initial U.S. Approval: 1985
50383-978-04	2024-01-30	C162847	48780-1	1030e365-1eef-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE LOTION safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE LOTION. CLOBETASOL PROPIONATE lotion, for topical use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50383-978-02	Clobetasol Propionate	1 in 1 CARTON	LOTION	1	6
50383-978-02	Clobetasol Propionate	59 mL in 1 BOTTLE	LOTION	59	6
50383-978-04	Clobetasol Propionate	1 in 1 CARTON	LOTION	1	6
50383-978-04	Clobetasol Propionate	118 mL in 1 BOTTLE	LOTION	118	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-978	CLOBETASOL PROPIONATE LOTION [AKORN]	6	Legacy NDC, 4 package rows	20221111_31c443c8-3cb8-4250-93f3-4ae2b4659f0b.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861505	clobetasol propionate 0.05 % Topical Lotion	PSN	31c443c8-3cb8-4250-93f3-4ae2b4659f0b	6
861505	clobetasol propionate 0.5 MG/ML Topical Lotion	SCD	31c443c8-3cb8-4250-93f3-4ae2b4659f0b	6
861505	clobetasol propionate 0.05 % Topical Lotion	SY	31c443c8-3cb8-4250-93f3-4ae2b4659f0b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-978-02	50383097802	1 BOTTLE in 1 CARTON (50383-978-02) > 59 mL in 1 BOTTLE	1 bottle	2018-11-05	0000-00-00	No	No	Current
50383-978-04	50383097804	1 BOTTLE in 1 CARTON (50383-978-04) > 118 mL in 1 BOTTLE	1 bottle	2018-11-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobetasol Propionate	Akorn \| Akorn Operating Company LLC	2022-11-09	HUMAN PRESCRIPTION DRUG LABEL	6