Clobetasol Propionate

Product NDC: 52565-055
11-digit product format: 525650055
Labeler code: 52565
Product ID: 52565-055_4533cb56-c0eb-4541-885c-001b4f8bc9e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clobetasol Propionate
Dosage form: LOTION
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA208667
Marketing category: ANDA
Marketing start: 2016-11-29
Marketing end: 0000-00-00
Substance: CLOBETASOL PROPIONATE
Active strength: 0 mg/100mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52565-055		I	Inactivated by FDA	2026-08-03
excluded package	package	52565-055	52565-055-02	I	Inactivated by FDA	2026-08-03
excluded package	package	52565-055	52565-055-04	I	Inactivated by FDA	2026-08-03

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52565-055-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52565-055-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52565-055-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52565-055-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52565-055-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52565-055-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52565-055-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52565-055-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52565-055-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52565-055-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52565-055-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52565-055-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52565-055-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52565-055-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52565-055-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52565-055-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52565-055-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52565-055-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52565-055-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52565-055-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52565-055-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52565-055-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52565-055-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52565-055-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52565-055-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52565-055-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52565-055-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52565-055-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52565-055-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52565-055-04	`1332a3947898…`	`d4bfe170f9cd…`

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
A208667-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL			2016-11-29

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	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		2016-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208667-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2016-11-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208667-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208667-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208667-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208667-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208667-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208667-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208667-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208667-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208667-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208667-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208667-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208667-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208667-001	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208667-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208667-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208667-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208667-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208667-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208667-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208667-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208667-001	AB	1	`cb3db0bc1861…`

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
52565-055-02	2023-01-30	C162847	48780-1	f386c64a-0019-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE lotion safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE lotion. CLOBETASOL PROPIONATE lotion, for topical use. Initial U.S. Approval: 1985
52565-055-04	2023-01-30	C162847	48780-1	f386c64a-0019-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE lotion safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE lotion. CLOBETASOL PROPIONATE lotion, for topical use. Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52565-055-02	Clobetasol Propionate	59 mL in 1 BOTTLE	LOTION	59	2
52565-055-02	Clobetasol Propionate	1 in 1 CARTON	LOTION	1	2
52565-055-04	Clobetasol Propionate	118 mL in 1 BOTTLE	LOTION	118	2
52565-055-04	Clobetasol Propionate	1 in 1 CARTON	LOTION	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-055-02	ML - Milliliter	52565-055	16928129-1f09-471c-b7a8-266658f6a0f7	1	2017-03-06
52565-055-04	ML - Milliliter	52565-055	ab0d937b-0b74-4753-8b98-1c462db85aa2	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-055	CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE) LOTION [TELIGENT PHARMA, INC.]	2	Legacy NDC, 4 package rows	20190911_a12c2b51-710d-68cd-2531-1c28f9864d8f.zip

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
52565-055-02	52565005502	1 BOTTLE in 1 CARTON (52565-055-02) > 59 mL in 1 BOTTLE	1 bottle	2016-11-29	0000-00-00	No	No	Current
52565-055-04	52565005504	1 BOTTLE in 1 CARTON (52565-055-04) > 118 mL in 1 BOTTLE	1 bottle	2016-11-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobetasol Propionate	Preferred Pharmaceuticals, Inc.	2021-04-12	HUMAN PRESCRIPTION DRUG LABEL	2
Clobetasol Propionate	Teligent Pharma, Inc.	2016-11-29	HUMAN PRESCRIPTION DRUG LABEL	2