Clotrimazole and Betamethasone Dipropionate

Product NDC: 67296-2272
11-digit product format: 672962272
Labeler code: 67296
Product ID: 67296-2272_56cb491e-cbb9-0bef-e063-6294a90a6c79
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clotrimazole and Betamethasone Dipropionate
Dosage form: CREAM
Route: TOPICAL
Labeler: Redpharm Drug
Application: ANDA075673
Marketing category: ANDA
Marketing start: 2001-05-29
Substance: CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
Active strength: 10; .5 mg/g; mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075673-001	AB

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	RS	2001-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075673-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-05-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075673-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075673-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075673-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075673-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075673-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075673-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075673-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075673-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075673-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075673-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075673-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075673-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075673-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075673-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075673-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075673-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075673-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075673-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075673-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075673-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075673-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075673-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075673-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075673-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075673-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075673-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075673-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075673-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075673-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075673-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075673-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075673-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075673-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075673-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075673-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075673-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075673-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075673-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075673-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075673-001	AB	1	`f41ea6bd6efb…`

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: Clotrimazole and Betamethasone Dipropionate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	10 mg/g
BETAMETHASONE DIPROPIONATE	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G07GZ97H65	Internal UNII lookup
826Y60901U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308714	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
56cb4b1c-e0c6-25b2-e063-6394a90ac833	Available on FDA.report

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	REMEDYREPACK INC.	5c064fc8-0426-4608-90ee-93609a7e5547	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075673 application number: ANDA075673
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Redpharm Drug	56cb4b1c-e0c6-25b2-e063-6394a90ac833	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075673 application number: ANDA075673 ndc (product): 67296-2272
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Sun Pharmaceutical Industries, Inc.	1c18e5fc-bf82-47bc-bfd9-8d3e503569ba	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075673 application number: ANDA075673
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Sportpharm LLC	313dde2e-fb82-4786-988b-565d3e003c37	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075673 application number: ANDA075673
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Preferred Pharmaceuticals Inc.	196e24fc-3315-4366-ad40-51b7ea54b211	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075673 application number: ANDA075673
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	2eff5585-f013-42f0-b678-bb5406e8188c	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075673 application number: ANDA075673
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Advanced Rx Pharmacy of Tennessee, LLC	fe2ec7d2-23c2-e99f-e053-6294a90aa65a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075673 application number: ANDA075673
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	4320f2b8-ac47-40f4-9275-e7c5506e30e4	2024-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075673 application number: ANDA075673
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	NORTHSTAR RX LLC	8d03b9ba-f7a8-4fbf-9be1-83d815c2be45	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075673 application number: ANDA075673
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	b3f69dc2-2b88-4866-baea-aa3b3ed84fb1	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075673 application number: ANDA075673

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G07GZ97H65	CLOTRIMAZOLE	23593-75-1	CLOTRIMAZOLE
826Y60901U	BETAMETHASONE DIPROPIONATE	5593-20-4	BETAMETHASONE DIPROPIONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2272-1	67296227201	1 TUBE in 1 CARTON (67296-2272-1) / 15 g in 1 TUBE	1 tube	2016-08-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole and Betamethasone Dipropionate	Redpharm Drug	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	1