CLOBETASOL PROPIONATE

Product NDC: 71589-002
Requested package NDC: 71589-002-30
11-digit product format: 715890002
Labeler code: 71589
Product ID: 71589-002_25b5f1b0-4830-4b84-be9a-a1415e67809e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLOBETASOL PROPIONATE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Aleor Dermaceuticals Limited
Application: ANDA211800
Marketing category: ANDA
Marketing start: 2019-03-12
Marketing end: 0000-00-00
Substance: CLOBETASOL PROPIONATE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71589-002	71589-002-30	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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A211800-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211800-001	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	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`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	A211800-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211800-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211800-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211800-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211800-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211800-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211800-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211800-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211800-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211800-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211800-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211800-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211800-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211800-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211800-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211800-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211800-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211800-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211800-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211800-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211800-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211800-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211800-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211800-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211800-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211800-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211800-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211800-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211800-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211800-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211800-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211800-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211800-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211800-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211800-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211800-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211800-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211800-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211800-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211800-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71589-002-15	2025-02-27	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-30	2025-02-27	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-45	2025-02-27	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-60	2025-02-27	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-15	2024-01-30	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-30	2024-01-30	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-45	2024-01-30	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-60	2024-01-30	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

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	NuCare Pharmaceuticals, Inc.	4524d04c-de48-6671-e063-6294a90a0e33	2025-12-04	Adverse reactions	Exact identifier application applno (ANDA): 211800 application number: ANDA211800
Clobetasol Propionate	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	fc3ac7b5-0cd5-4d31-97e4-b01c0f715835	2025-03-28	Adverse reactions	Exact identifier application applno (ANDA): 211800 application number: ANDA211800
Clobetasol Propionate	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	1a4331e1-5c79-44c3-a691-4b808a3bde97	2025-02-12	Adverse reactions	Exact identifier application applno (ANDA): 211800 application number: ANDA211800

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
71589-002-30	71589000230	1 TUBE in 1 CARTON (71589-002-30) > 30 g in 1 TUBE	1 tube	2019-03-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLOBETASOL PROPIONATE	Aleor Dermaceuticals Limited \| Encube Ethicals Pvt. Ltd.	2019-08-01	HUMAN PRESCRIPTION DRUG LABEL	1