clobetasol propionate

Product NDC: 45802-961
11-digit product format: 458020961
Labeler code: 45802
Product ID: 45802-961_4fa40080-5565-4900-b95b-c07f05c7f789
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clobetasol Propionate
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA090974
Marketing category: ANDA
Marketing start: 2012-08-10
Substance: CLOBETASOL PROPIONATE
Active strength: .05 g/100mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A090974-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB		2012-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090974-001	AB

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	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090974-001	CLOBETASOL PROPIONATE	0.05%	SHAMPOO / TOPICAL	AB	2012-08-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090974-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090974-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090974-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090974-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090974-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090974-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090974-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090974-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090974-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090974-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090974-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090974-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090974-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090974-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090974-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090974-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090974-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090974-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090974-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090974-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090974-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090974-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090974-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090974-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090974-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090974-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090974-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090974-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090974-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090974-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090974-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090974-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090974-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090974-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090974-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090974-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090974-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090974-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090974-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090974-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: clobetasol propionate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOBETASOL PROPIONATE	.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
779619577M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861490	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
49bfff2e-9e4d-48a4-9f74-d6cf5b312aca	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-961-26	clobetasol propionate	118 mL in 1 BOTTLE	SHAMPOO	118		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-961-26	ML - Milliliter	45802-961	d0639ffa-ecb8-4990-b88c-e311758abfb8	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOBETASOL PROPIONATE	ACTIVE INGREDIENT	779619577M	CLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]	6
CLOBETASOL	ACTIVE MOIETY	ADN79D536H	CLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]	6
COCO-BETAINE	INACTIVE INGREDIENT	03DH2IZ3FY	CLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]	6
SODIUM LAURETH-3 SULFATE	INACTIVE INGREDIENT	BPV390UAP0	CLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOBETASOL PROPIONATE SHAMPOO [PERRIGO NEW YORK INC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-961	CLOBETASOL PROPIONATE SHAMPOO [PADAGIS ISRAEL PHARMACEUTICALS LTD]	13	Current NDC, Legacy NDC, 1 package rows	20240926_49bfff2e-9e4d-48a4-9f74-d6cf5b312aca.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clobetasol propionate	CLOBETASOL PROPIONATE	Padagis Israel Pharmaceuticals Ltd	49bfff2e-9e4d-48a4-9f74-d6cf5b312aca	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090974 application number: ANDA090974 ndc (product): 45802-961
clobetasol propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	40c3b94f-a61c-4fc1-a411-5bf4e3fe6791	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090974 application number: ANDA090974
clobetasol propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	2d0b48d9-dbfb-4265-b73b-07faf217ae6e	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090974 application number: ANDA090974
Clodan	CLOBETASOL PROPIONATE	Medimetriks Pharmaceuticals	b5d32546-65dc-4b0c-826e-ddbc2a50b152	2023-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090974 application number: ANDA090974

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
861490	clobetasol propionate 0.05 % Medicated Shampoo	PSN	40c3b94f-a61c-4fc1-a411-5bf4e3fe6791	104
861490	clobetasol propionate 0.5 MG/ML Medicated Shampoo	SCD	40c3b94f-a61c-4fc1-a411-5bf4e3fe6791	104
861490	clobetasol propionate 0.05 % Medicated Shampoo	SY	40c3b94f-a61c-4fc1-a411-5bf4e3fe6791	104
861490	clobetasol propionate 0.05 % Medicated Shampoo	PSN	2d0b48d9-dbfb-4265-b73b-07faf217ae6e	100
861490	clobetasol propionate 0.5 MG/ML Medicated Shampoo	SCD	2d0b48d9-dbfb-4265-b73b-07faf217ae6e	100
861490	clobetasol propionate 0.05 % Medicated Shampoo	SY	2d0b48d9-dbfb-4265-b73b-07faf217ae6e	100
861490	clobetasol propionate 0.05 % Medicated Shampoo	PSN	49bfff2e-9e4d-48a4-9f74-d6cf5b312aca	13
861490	clobetasol propionate 0.5 MG/ML Medicated Shampoo	SCD	49bfff2e-9e4d-48a4-9f74-d6cf5b312aca	13
861490	clobetasol propionate 0.05 % Medicated Shampoo	SY	49bfff2e-9e4d-48a4-9f74-d6cf5b312aca	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-961-26	45802096126	118 mL in 1 BOTTLE (45802-961-26)	118 ml	2012-08-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
clobetasol propionate - Padagis Israel Pharmaceuticals Ltd	Padagis Israel Pharmaceuticals Ltd	2025-11-30	HUMAN PRESCRIPTION DRUG LABEL	14
clobetasol propionate - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	104
clobetasol propionate - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-04-02	HUMAN PRESCRIPTION DRUG LABEL	100