Home NDC 51672-1260 Clotrimazole
Product NDC 51672-1260
11-digit product format 516721260
Labeler code 51672
Product ID 51672-1260_390848b9-e9c6-c3c4-e063-6294a90a5b26
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clotrimazole
Dosage form SOLUTION
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA074580
Marketing category ANDA
Marketing start 1996-07-29
Substance CLOTRIMAZOLE
Active strength 10 mg/mL
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
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 1 .
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 · 41 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 2026-02-19 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…2022-09-29 23:25 UTC 2022-09 A074580-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT RS 1996-07-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074580-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT RS 1996-07-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clotrimazole
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1260-3 Clotrimazole 1 in 1 CARTON SOLUTION 1 4 51672-1260-3 Clotrimazole 30 mL in 1 BOTTLE, PLASTIC SOLUTION 30 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1260 CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 Current NDC, Legacy NDC, 2 package rows 20170508_3e2041a0-8bef-4be4-b2b1-556446c4a778.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51672-1260-3 51672126003 1 BOTTLE, PLASTIC in 1 CARTON (51672-1260-3) / 30 mL in 1 BOTTLE, PLASTIC 1996-07-29 0000-00-00 No No Current