Clobetasol Propionate

Product NDC: 13668-569
11-digit product format: 136680569
Labeler code: 13668
Product ID: 13668-569_e105f3a8-2dee-4547-9760-35e7a1da464a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clobetasol Propionate
Dosage form: CREAM
Route: TOPICAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA211836
Marketing category: ANDA
Marketing start: 2024-12-15
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

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 · 10 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
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	13668-569-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-569-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-569-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-569-05	`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	13668-569-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-569-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-569-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-569-05	`367a005e9d99…`	`383a685ebd0f…`

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
A211836-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1		2019-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211836-001	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.

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	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2019-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211836-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2019-12-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211836-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211836-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211836-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211836-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211836-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211836-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211836-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211836-001	AB1	1	`2680178bc6a6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211836-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211836-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211836-001	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211836-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211836-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211836-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211836-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211836-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211836-001	AB1	1	`c0c555d07b60…`
2023-01-26 05:58 UTC	2023-01	A211836-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211836-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211836-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211836-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211836-001	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211836-001	AB1	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
861495	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
6f930298-e410-4bfb-8c3f-456a1f55f4a9	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13668-569-01	Clobetasol Propionate	15 g in 1 TUBE	CREAM	15	10
13668-569-02	Clobetasol Propionate	30 g in 1 TUBE	CREAM	30	10
13668-569-04	Clobetasol Propionate	45 g in 1 TUBE	CREAM	45	10
13668-569-05	Clobetasol Propionate	60 g in 1 TUBE	CREAM	60	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-569-01	GM - Gram	13668-569	cf11b395-b44a-4b70-9cc0-a6a505e2db07	1	2021-08-05
13668-569-02	GM - Gram	13668-569	7581ea3c-f576-4055-a1ab-40dff47b6bef	1	2021-08-05
13668-569-04	GM - Gram	13668-569	75fda5dc-ef5e-4ba2-8b49-1e6adca32b63	1	2021-09-07
13668-569-05	GM - Gram	13668-569	145e4eed-ea4b-4b42-bb33-e23d16b6e923	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-569	CLOBETASOL PROPIONATE CREAM [TORRENT PHARMACEUTICALS LIMITED]	9	Current NDC, Legacy NDC, 4 package rows	20241215_6f930298-e410-4bfb-8c3f-456a1f55f4a9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	Torrent Pharmaceuticals Limited	6f930298-e410-4bfb-8c3f-456a1f55f4a9	2026-05-08	Adverse reactions	Exact identifier application applno (ANDA): 211836 application number: ANDA211836 ndc (product): 13668-569

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	6f930298-e410-4bfb-8c3f-456a1f55f4a9	10
861495	clobetasol propionate 0.5 MG/ML Topical Cream	SCD	6f930298-e410-4bfb-8c3f-456a1f55f4a9	10
861495	clobetasol propionate 0.05 % Topical Cream	SY	6f930298-e410-4bfb-8c3f-456a1f55f4a9	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-569-01	13668056901	15 g in 1 TUBE (13668-569-01)	15 g	2024-12-15	0000-00-00	No	No	Current
13668-569-02	13668056902	30 g in 1 TUBE (13668-569-02)	30 g	2024-12-15	0000-00-00	No	No	Current
13668-569-04	13668056904	45 g in 1 TUBE (13668-569-04)	45 g	2024-12-15	0000-00-00	No	No	Current
13668-569-05	13668056905	60 g in 1 TUBE (13668-569-05)	60 g	2024-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobetasol Propionate	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-05-08	HUMAN PRESCRIPTION DRUG LABEL	10