CLOBETASOL PROPIONATE

Product NDC: 68462-480
11-digit product format: 684620480
Labeler code: 68462
Product ID: 68462-480_fdb792f3-5d06-45e2-8a04-a7cd39b2f0b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLOBETASOL PROPIONATE
Dosage form: SPRAY
Route: TOPICAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA209004
Marketing category: ANDA
Marketing start: 2018-03-26
Marketing end: 0000-00-00
Substance: CLOBETASOL PROPIONATE
Active strength: 0 g/mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	68462-480		D	Discontinued by firm	2026-10-28
excluded package	package	68462-480	68462-480-39	D	Discontinued by firm	2026-10-28
excluded package	package	68462-480	68462-480-56	D	Discontinued by firm	2026-10-28

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A209004-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL			2018-03-26

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 · 44 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
2026-10-15 13:18:30	2026-09	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL		2018-03-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL		2018-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL		2018-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL		2018-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL		2018-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL		2018-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209004-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2018-03-26	`3a93d1ddd44b…`

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	A209004-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209004-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209004-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209004-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209004-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209004-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209004-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209004-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209004-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209004-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209004-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209004-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209004-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209004-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209004-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209004-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209004-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209004-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209004-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209004-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209004-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209004-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209004-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209004-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209004-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209004-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209004-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209004-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209004-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209004-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209004-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209004-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209004-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209004-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209004-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209004-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209004-001	AT	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

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
68462-480-39	CLOBETASOL PROPIONATE	59 mL in 1 BOTTLE	SPRAY	59	4
68462-480-39	CLOBETASOL PROPIONATE	1 in 1 CARTON	SPRAY	1	4
68462-480-56	CLOBETASOL PROPIONATE	1 in 1 CARTON	SPRAY	1	4
68462-480-56	CLOBETASOL PROPIONATE	125 mL in 1 BOTTLE	SPRAY	125	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-480-39	ML - Milliliter	68462-480	0257d8cc-b31d-4a0f-865c-7b335c7c0a5d	1	2018-06-11
68462-480-56	ML - Milliliter	68462-480	42018bd9-9b72-4914-b504-20f2231fa741	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-480	CLOBETASOL PROPIONATE SPRAY [GLENMARK PHARMACEUTICALS INC., USA]	4	Legacy NDC, 4 package rows	20240104_dfc58f73-e892-4fc3-8726-4e8d1546ebd3.zip

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
861512	clobetasol propionate 0.05 % Topical Spray	PSN	dfc58f73-e892-4fc3-8726-4e8d1546ebd3	4
861512	clobetasol propionate 0.5 MG/ML Topical Spray	SCD	dfc58f73-e892-4fc3-8726-4e8d1546ebd3	4
861512	clobetasol propionate 0.05 % Topical Spray	SY	dfc58f73-e892-4fc3-8726-4e8d1546ebd3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-480-39	68462048039	1 BOTTLE in 1 CARTON (68462-480-39) > 59 mL in 1 BOTTLE	1 bottle	2018-03-26	0000-00-00	No	No	Current
68462-480-56	68462048056	1 BOTTLE in 1 CARTON (68462-480-56) > 125 mL in 1 BOTTLE	1 bottle	2018-03-26	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	2020-09-07	HUMAN PRESCRIPTION DRUG LABEL	4