Clobetasol Propionate

Product NDC: 68071-2764
11-digit product format: 680712764
Labeler code: 68071
Product ID: 68071-2764_e1854cc8-fae0-39d6-e053-2a95a90aad4b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clobetasol Propionate
Dosage form: CREAM
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA211256
Marketing category: ANDA
Marketing start: 2018-12-28
Marketing end: 0000-00-00
Substance: CLOBETASOL PROPIONATE
Active strength: 1 mg/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2764		I	Inactivated by FDA		2026-08-17
excluded package	package	68071-2764	68071-2764-1	I	Inactivated by FDA		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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2764-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2764-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2764-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2764-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2764-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2764-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2764-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2764-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2764-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A211256-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1		2018-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211256-001	AB1

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	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211256-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-12-26	`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	A211256-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211256-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211256-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211256-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211256-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211256-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211256-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211256-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211256-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211256-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211256-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211256-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211256-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211256-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211256-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211256-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211256-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211256-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211256-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211256-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211256-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211256-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211256-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211256-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211256-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211256-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211256-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211256-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211256-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211256-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211256-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211256-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211256-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211256-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211256-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211256-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211256-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211256-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211256-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211256-001	AB1	1	`e64feba35796…`

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
68071-2764-1	2025-01-30	C162847	48780-1	2cef2736-ae2b-d83d-e063-dadaa90ab31f	Clobetasol Propionate Cream, USP 0.05% FOR TOPICAL DERMATOLOGIC USE ONLY— NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2764-1	Clobetasol Propionate	1 in 1 CARTON	CREAM	1		1
68071-2764-1	Clobetasol Propionate	15 g in 1 TUBE	CREAM	15		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2764	CLOBETASOL PROPIONATE CREAM [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 2 package rows	20220618_e1854cfc-9b3b-5fad-e053-2a95a90a73e8.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	AvKARE	a86241e0-3187-e468-e053-2995a90a1ae5	2026-07-15	Adverse reactions	Exact identifier application applno (ANDA): 211256 application number: ANDA211256
Clobetasol Propionate	CLOBETASOL PROPIONATE	Amneal Pharmaceuticals NY LLC	53871de0-30cc-4446-b2a0-7a10caa965e0	2023-12-29	Adverse reactions	Exact identifier application applno (ANDA): 211256 application number: ANDA211256
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	e223598e-3cf8-4362-b963-a23ea05072ba	2023-10-16	Adverse reactions	Exact identifier application applno (ANDA): 211256 application number: ANDA211256

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
861495	clobetasol propionate 0.05 % Topical Cream	PSN	e1854cfc-9b3b-5fad-e053-2a95a90a73e8	1
861495	clobetasol propionate 0.5 MG/ML Topical Cream	SCD	e1854cfc-9b3b-5fad-e053-2a95a90a73e8	1
861495	clobetasol propionate 0.05 % Topical Cream	SY	e1854cfc-9b3b-5fad-e053-2a95a90a73e8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2764-1	68071276401	1 TUBE in 1 CARTON (68071-2764-1) > 15 g in 1 TUBE	1 tube	2022-06-16	0000-00-00	No	No	Current