CLOBETASOL PROPIONATE

Product NDC: 68462-532
Requested package NDC: 68462-532-53
11-digit product format: 684620532
Labeler code: 68462
Product ID: 68462-532_8a5a06f3-bb61-4854-8c74-673747cbcfdd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLOBETASOL PROPIONATE
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA210190
Marketing category: ANDA
Marketing start: 2018-04-18
Substance: CLOBETASOL PROPIONATE
Active strength: .5 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210190-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL			2018-04-18

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 · 43 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
2026-09-14 22:38:34	2026-08	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2018-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2018-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2018-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2018-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2018-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210190-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2018-04-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210190-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210190-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210190-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210190-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210190-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210190-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210190-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210190-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210190-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210190-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210190-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210190-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210190-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210190-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210190-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210190-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210190-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210190-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210190-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210190-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210190-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210190-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210190-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210190-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210190-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210190-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210190-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210190-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210190-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210190-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210190-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210190-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210190-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210190-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210190-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210190-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210190-001	AT	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: CLOBETASOL PROPIONATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOBETASOL PROPIONATE	.5 mg/mL

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
861487	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
e37dd885-889a-4bfd-9813-bb7b9b96cee1	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
68462-532-28	CLOBETASOL PROPIONATE	25 mL in 1 BOTTLE	SOLUTION	25	5
68462-532-28	CLOBETASOL PROPIONATE	1 in 1 CARTON	SOLUTION	1	5
68462-532-53	CLOBETASOL PROPIONATE	50 mL in 1 BOTTLE	SOLUTION	50	5
68462-532-53	CLOBETASOL PROPIONATE	1 in 1 CARTON	SOLUTION	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-532-28	ML - Milliliter	68462-532	c0730222-08ce-4230-b253-a87ac2855ad3	1	2018-07-03
68462-532-53	ML - Milliliter	68462-532	fabe498d-00b8-4652-b514-fc05e197eac5	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-532	CLOBETASOL PROPIONATE SOLUTION [GLENMARK PHARMACEUTICALS INC., USA]	5	Current NDC, Legacy NDC, 4 package rows	20240104_e37dd885-889a-4bfd-9813-bb7b9b96cee1.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	Glenmark Pharmaceuticals Inc., USA	e37dd885-889a-4bfd-9813-bb7b9b96cee1	2018-04-18	Adverse reactions	Exact identifier application applno (ANDA): 210190 application number: ANDA210190 ndc (package): 68462-532-53 ndc (product): 68462-532 ndc11 (package): 68462053253

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
861487	clobetasol propionate 0.05 % Topical Solution	PSN	e37dd885-889a-4bfd-9813-bb7b9b96cee1	5
861487	clobetasol propionate 0.5 MG/ML Topical Solution	SCD	e37dd885-889a-4bfd-9813-bb7b9b96cee1	5
861487	clobetasol propionate 0.05 % Topical Solution	SY	e37dd885-889a-4bfd-9813-bb7b9b96cee1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-532-53	68462053253	1 BOTTLE in 1 CARTON (68462-532-53) / 50 mL in 1 BOTTLE	1 bottle	2018-04-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2018-04-18	HUMAN PRESCRIPTION DRUG LABEL	5