CLOBETASOL PROPIONATE

Product NDC: 62332-547
11-digit product format: 623320547
Labeler code: 62332
Product ID: 62332-547_38759a63-edf0-4435-9333-d8c87eae8475
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLOBETASOL PROPIONATE
Dosage form: CREAM
Route: TOPICAL
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA213291
Marketing category: ANDA
Marketing start: 2020-01-31
Substance: CLOBETASOL PROPIONATE
Active strength: .5 mg/g
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 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
A213291-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1		2020-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213291-001	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	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213291-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2020-01-27	`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	A213291-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213291-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213291-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213291-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213291-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213291-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213291-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213291-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213291-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213291-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213291-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213291-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213291-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213291-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213291-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213291-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213291-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213291-001	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213291-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213291-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213291-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213291-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213291-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213291-001	AB1	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213291-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213291-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213291-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213291-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213291-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213291-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213291-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213291-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213291-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213291-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213291-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213291-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213291-001	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213291-001	AB1	1	`a50c72e98297…`

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/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
0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
1c87bbde-dd91-a122-db33-67ae814cb645	Product name	7	20210510
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
519b5875-7d7d-4aa6-9d3d-470fa1376595	Product name	4	20200227
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
98669154-3e9c-47da-8a2c-656ab71848be	Product name	2	20180607
8d4f8539-436f-453b-8b76-5322d403fc8e	Product name	1	20180131
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
62332-547-15	CLOBETASOL PROPIONATE	1 in 1 CARTON	CREAM	1	10
62332-547-15	CLOBETASOL PROPIONATE	15 g in 1 TUBE	CREAM	15	10
62332-547-30	CLOBETASOL PROPIONATE	1 in 1 CARTON	CREAM	1	10
62332-547-30	CLOBETASOL PROPIONATE	30 g in 1 TUBE	CREAM	30	10
62332-547-45	CLOBETASOL PROPIONATE	45 g in 1 TUBE	CREAM	45	10
62332-547-45	CLOBETASOL PROPIONATE	1 in 1 CARTON	CREAM	1	10
62332-547-60	CLOBETASOL PROPIONATE	60 g in 1 TUBE	CREAM	60	10
62332-547-60	CLOBETASOL PROPIONATE	1 in 1 CARTON	CREAM	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62332-547-15	GM - Gram	62332-547	9a7441cc-ce04-4680-8778-9c4a285995ff	1	2020-07-13
62332-547-30	GM - Gram	62332-547	2758720e-16cc-4c1f-a925-e58e20c2d2cb	1	2020-07-13
62332-547-45	GM - Gram	62332-547	a247d53a-5ce9-4084-a0c5-fb6ce7eee09f	1	2020-07-13
62332-547-60	GM - Gram	62332-547	aebc9ba8-d8aa-4bb6-9118-d783baab2375	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-547	CLOBETASOL PROPIONATE CREAM [ALEMBIC PHARMACEUTICALS INC.]	10	Current NDC, Legacy NDC, 8 package rows	20240327_0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	a4f74fc7-d2f6-4cf2-9cc5-60078bde55a7	2025-03-26	Adverse reactions	Exact identifier application applno (ANDA): 213291 application number: ANDA213291
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb	2024-03-14	Adverse reactions	Exact identifier application applno (ANDA): 213291 application number: ANDA213291 ndc (product): 62332-547

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	0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb	10
861495	clobetasol propionate 0.5 MG/ML Topical Cream	SCD	0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb	10
861495	clobetasol propionate 0.05 % Topical Cream	SY	0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62332-547-15	62332054715	1 TUBE in 1 CARTON (62332-547-15) / 15 g in 1 TUBE	1 tube	2020-01-31	0000-00-00	No	No	Current
62332-547-30	62332054730	1 TUBE in 1 CARTON (62332-547-30) / 30 g in 1 TUBE	1 tube	2020-01-31	0000-00-00	No	No	Current
62332-547-45	62332054745	1 TUBE in 1 CARTON (62332-547-45) / 45 g in 1 TUBE	1 tube	2020-01-31	0000-00-00	No	No	Current
62332-547-60	62332054760	1 TUBE in 1 CARTON (62332-547-60) / 60 g in 1 TUBE	1 tube	2020-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited	2024-03-14	HUMAN PRESCRIPTION DRUG LABEL	10