Clotrimazole

Product NDC: 67296-2252
11-digit product format: 672962252
Labeler code: 67296
Product ID: 67296-2252_53cb3b8e-e8d2-fffc-e063-6294a90ac814
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: TOPICAL
Labeler: Redpharm Drug
Application: ANDA090219
Marketing category: ANDA
Marketing start: 2010-08-04
Substance: CLOTRIMAZOLE
Active strength: 10 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
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
A090219-001	CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB		2010-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090219-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2010-08-03	`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	A090219-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090219-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090219-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090219-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090219-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090219-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090219-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090219-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090219-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090219-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090219-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090219-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090219-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090219-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090219-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090219-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090219-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090219-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090219-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090219-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090219-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090219-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090219-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090219-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090219-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090219-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090219-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090219-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090219-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090219-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090219-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090219-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090219-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090219-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090219-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090219-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090219-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090219-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090219-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090219-001	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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309367	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
53cafc9f-7761-83a9-e063-6294a90a3437	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	Redpharm Drug	53cafc9f-7761-83a9-e063-6294a90a3437	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090219 application number: ANDA090219 ndc (product): 67296-2252
Clotrimazole	CLOTRIMAZOLE	Glenmark Pharmaceuticals Inc., USA	f6898117-14f3-42d2-bc0e-d296add3ad70	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090219 application number: ANDA090219
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	116be3a8-9a57-4b4a-a873-98a4ce83bcf7	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090219 application number: ANDA090219

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G07GZ97H65	CLOTRIMAZOLE	23593-75-1	CLOTRIMAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2252-3	67296225203	30 g in 1 TUBE (67296-2252-3)	30 g	2010-08-04	No	No	Current