Clobetasol Propionate

Product NDC: 63629-8639
11-digit product format: 636298639
Labeler code: 63629
Product ID: 63629-8639_c7c7cb6a-e121-480a-abbc-cc1a5202cb69
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clobetasol propionate
Dosage form: GEL
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA075027
Marketing category: ANDA
Marketing start: 2008-07-30
Substance: CLOBETASOL PROPIONATE
Active strength: .5 mg/g
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 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
A075027-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB		1997-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075027-001	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 · 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	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075027-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075027-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075027-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075027-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075027-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075027-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075027-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075027-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075027-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075027-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075027-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075027-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075027-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075027-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075027-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075027-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075027-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075027-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075027-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075027-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075027-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075027-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075027-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075027-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075027-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075027-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075027-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075027-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075027-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075027-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075027-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075027-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075027-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075027-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075027-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075027-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075027-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075027-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075027-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075027-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clobetasol Propionate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOBETASOL PROPIONATE	.5 mg/g

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
861434	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
1bdc1978-00d1-43f4-a127-a9d9c709644d	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
63629-8639-1	Clobetasol Propionate	60 g in 1 TUBE	GEL	60		104
63629-8639-1	Clobetasol Propionate	1 in 1 CARTON	GEL	1		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8639-1	GM - Gram	63629-8639	27f00208-3c81-4b66-9a45-0a53977da331	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8639	CLOBETASOL PROPIONATE GEL [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 2 package rows	20241101_1bdc1978-00d1-43f4-a127-a9d9c709644d.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	f0ca99cd-6c54-44f8-a9b3-432e93fc5d59	2025-10-08	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	1bdc1978-00d1-43f4-a127-a9d9c709644d	2024-10-30	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027 ndc (product): 63629-8639
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	bc021c6c-43db-469c-b1c3-0166b18daea4	2023-07-17	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	695b2b8a-9d8c-4e94-bc78-2f535b8e2cbc	2023-07-17	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027
Clobetasol Propionate	CLOBETASOL PROPIONATE	Padagis Israel Pharmaceuticals Ltd	f9df643a-015d-4101-ac8f-c1e05b052df5	2023-03-01	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027

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
861434	clobetasol propionate 0.05 % Topical Gel	PSN	1bdc1978-00d1-43f4-a127-a9d9c709644d	104
861434	clobetasol propionate 0.0005 MG/MG Topical Gel	SCD	1bdc1978-00d1-43f4-a127-a9d9c709644d	104
861434	clobetasol propionate 0.05 % Topical Gel	SY	1bdc1978-00d1-43f4-a127-a9d9c709644d	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8639-1	63629863901	1 TUBE in 1 CARTON (63629-8639-1) / 60 g in 1 TUBE	1 tube	2008-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobetasol Propionate Gel, 0.05%	Bryant Ranch Prepack	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	104