Clobetasol Propionate

Product NDC: 68788-7963
11-digit product format: 687887963
Labeler code: 68788
Product ID: 68788-7963_ff9104d2-9ae3-4205-995d-8df11c95e505
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clobetasol Propionate Ointment, 0.05%
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA211295
Marketing category: ANDA
Marketing start: 2021-07-19
Substance: CLOBETASOL PROPIONATE
Active strength: .5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A211295-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211295-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211295-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211295-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211295-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211295-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211295-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211295-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211295-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211295-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211295-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211295-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211295-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211295-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211295-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211295-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211295-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211295-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211295-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211295-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211295-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211295-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211295-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211295-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211295-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211295-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211295-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211295-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211295-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211295-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211295-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211295-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211295-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211295-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211295-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211295-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211295-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211295-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211295-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211295-001	AB	1	`a50c72e98297…`

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	.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
861448	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
087c5aee-d7fd-42ce-b213-14c810292808	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	SPL version
68788-7963-1	Clobetasol Propionate	15 g in 1 TUBE	OINTMENT	15	7
68788-7963-1	Clobetasol Propionate	1 in 1 CARTON	OINTMENT	1	7
68788-7963-3	Clobetasol Propionate	1 in 1 CARTON	OINTMENT	1	7
68788-7963-3	Clobetasol Propionate	30 g in 1 TUBE	OINTMENT	30	7
68788-7963-6	Clobetasol Propionate	60 g in 1 TUBE	OINTMENT	60	7
68788-7963-6	Clobetasol Propionate	1 in 1 CARTON	OINTMENT	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7963-1	GM - Gram	68788-7963	9101650e-e188-4c34-9e78-2d167d998a43	1	2021-08-05
68788-7963-3	GM - Gram	68788-7963	c4c90402-bd84-4a6f-8e04-d038b96ef05c	1	2021-08-05
68788-7963-6	GM - Gram	68788-7963	8e13f462-284d-4127-961b-7188ae876821	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7963	CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT, 0.05%) OINTMENT [PREFERRED PHARMACEUTICALS INC.]	5	Current NDC, Legacy NDC, 6 package rows	20250308_087c5aee-d7fd-42ce-b213-14c810292808.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Encube Ethicals, Inc.	1f076779-3f76-47d5-99f0-9b0b2d3f5fac	2026-07-09	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT, 0.05%	Preferred Pharmaceuticals Inc.	087c5aee-d7fd-42ce-b213-14c810292808	2026-03-30	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295 ndc (product): 68788-7963
Clobetasol Propionate	CLOBETASOL PROPIONATE USP, 0.05%	A-S Medication Solutions	485e931d-16a7-4e92-996e-d3b32d9f41e7	2025-12-06	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	4d9b83e8-593e-4add-ac1d-c8eea25761bc	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	7c71c9a8-9c76-4de4-982f-42eb54b7689c	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	fa0e3c04-4b45-4aca-8b59-7df2ec3963e7	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	09717dc5-eef3-4f50-a346-f91d7e86fec9	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	60f65ee3-b972-4e58-97fe-0c0ab14b9b48	2025-10-21	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	d6a0f4ca-dd42-4af3-85e5-8c61c0ba6ae2	2025-01-24	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	032f1f4e-1f1c-409a-8fac-6449ee543caa	2025-01-24	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	3dcc49e7-a4f8-44cf-9405-2786bdc910cb	2025-01-24	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	c57776d2-06d7-4019-95df-ff38f721dec5	2024-04-12	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295

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
861448	clobetasol propionate 0.05 % Topical Ointment	PSN	087c5aee-d7fd-42ce-b213-14c810292808	7
861448	clobetasol propionate 0.0005 MG/MG Topical Ointment	SCD	087c5aee-d7fd-42ce-b213-14c810292808	7
861448	clobetasol propionate 0.05 % Topical Ointment	SY	087c5aee-d7fd-42ce-b213-14c810292808	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7963-1	68788796301	1 TUBE in 1 CARTON (68788-7963-1) / 15 g in 1 TUBE	1 tube	2021-07-19	0000-00-00	No	No	Current
68788-7963-3	68788796303	1 TUBE in 1 CARTON (68788-7963-3) / 30 g in 1 TUBE	1 tube	2021-07-19	0000-00-00	No	No	Current
68788-7963-6	68788796306	1 TUBE in 1 CARTON (68788-7963-6) / 60 g in 1 TUBE	1 tube	2021-07-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobetasol Propionate Ointment, 0.05%	Preferred Pharmaceuticals Inc.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	7