Clobetasol Propionate

Product NDC: 0472-0403
11-digit product format: 004720403
Labeler code: 0472
Product ID: 0472-0403_69a83d92-46be-4387-9d1c-f36e640f56ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clobetasol Propionate
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: ANDA078854
Marketing category: ANDA
Marketing start: 2012-01-03
Marketing end: 0000-00-00
Substance: CLOBETASOL PROPIONATE
Active strength: 0 g/100mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0472-0403		D	Discontinued by firm		2026-08-17
excluded package	package	0472-0403	0472-0403-94	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0472-0403		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0472-0403	0472-0403-94	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078854-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL			2011-06-07

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 · 42 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
2026-08-18 06:07:40	2026-07	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL		2011-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078854-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2011-06-07	`e64feba35796…`

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	A078854-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078854-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078854-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078854-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078854-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078854-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078854-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078854-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078854-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078854-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078854-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078854-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078854-001	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078854-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078854-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078854-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078854-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078854-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078854-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078854-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078854-001	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-0403-94	ML - Milliliter	0472-0403	3429704d-61a4-46b8-9b83-2cae939b1e64	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 SHAMPOO [ACTAVIS MID ATLANTIC LLC]	2
CLOBETASOL	ACTIVE MOIETY	ADN79D536H	CLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]	2
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	CLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]	2
POLYQUATERNIUM-10 (400 CPS AT 2%)	INACTIVE INGREDIENT	HB1401PQFS	CLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]	2
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	CLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOBETASOL PROPIONATE SHAMPOO [ACTAVIS MID ATLANTIC LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0472-0403	CLOBETASOL PROPIONATE SHAMPOO [ACTAVIS PHARMA, INC.]	8	Legacy NDC	20241222_9539c24e-3fc4-44a6-a40c-bb53260df2f2.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
0472-0403-94	00472040394	1 BOTTLE in 1 CARTON (0472-0403-94) > 118 mL in 1 BOTTLE	1 bottle	2012-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobetasol Propionate - Actavis Pharma, Inc.	Actavis Pharma, Inc.	2018-08-01	HUMAN PRESCRIPTION DRUG LABEL	8