Clotrimazole

Product NDC: 68788-4155
Requested package NDC: 68788-4155-3
11-digit product format: 687884155
Labeler code: 68788
Product ID: 68788-4155_c64e2290-593f-48a2-a15d-41689f836fda
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clotrimazole
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA074580
Marketing category: ANDA
Marketing start: 2026-07-16
Substance: CLOTRIMAZOLE
Active strength: 10 mg/mL
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
A074580-001	CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074580-001	AT

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	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074580-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	RS	1996-07-29	`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	A074580-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074580-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074580-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074580-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074580-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074580-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074580-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074580-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074580-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074580-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074580-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074580-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074580-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074580-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074580-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074580-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074580-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074580-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074580-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074580-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074580-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074580-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074580-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074580-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074580-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074580-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074580-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074580-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074580-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074580-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074580-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074580-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074580-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074580-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074580-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074580-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074580-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074580-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074580-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074580-001	AT	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/mL

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
309370	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
c64e2290-593f-48a2-a15d-41689f836fda	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	c64e2290-593f-48a2-a15d-41689f836fda	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074580 application number: ANDA074580 ndc (package): 68788-4155-3 ndc (product): 68788-4155 ndc11 (package): 68788415503
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	3e2041a0-8bef-4be4-b2b1-556446c4a778	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074580 application number: ANDA074580

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	Marketing start	Sample	Exclude flag	Status
68788-4155-3	68788415503	1 BOTTLE, PLASTIC in 1 CARTON (68788-4155-3) / 30 mL in 1 BOTTLE, PLASTIC	2026-07-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole Topical Solution USP, 1%	Preferred Pharmaceuticals Inc.	2026-07-16	HUMAN PRESCRIPTION DRUG LABEL	1