Home NDC 51672-1275 Clotrimazole
Product NDC 51672-1275
11-digit product format 516721275
Labeler code 51672
Product ID 51672-1275_3e748b32-1a66-10b0-e063-6394a90a7321
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA072640
Marketing category ANDA
Marketing start 1993-08-31
Substance CLOTRIMAZOLE
Active strength 10 mg/g
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 A072640-001 CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072640-001 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 · 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 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 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/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.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Clotrimazole ACTIVE INGREDIENT G07GZ97H65 CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Clotrimazole ACTIVE MOIETY G07GZ97H65 CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 cetyl esters wax INACTIVE INGREDIENT D072FFP9GU CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 CLOTRIMAZOLE ACTIVE INGREDIENT G07GZ97H65 CLOTRIMAZOLE CREAM [STAT RX USA LLC] 1 CLOTRIMAZOLE ACTIVE INGREDIENT G07GZ97H65 CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 CLOTRIMAZOLE ACTIVE MOIETY G07GZ97H65 CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 CLOTRIMAZOLE ACTIVE MOIETY G07GZ97H65 CLOTRIMAZOLE CREAM [STAT RX USA LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CLOTRIMAZOLE CREAM [STAT RX USA LLC] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CLOTRIMAZOLE CREAM [STAT RX USA LLC] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 CETYL ESTERS WAX INACTIVE INGREDIENT D072FFP9GU CLOTRIMAZOLE CREAM [STAT RX USA LLC] 1 CETYL ESTERS WAX INACTIVE INGREDIENT D072FFP9GU CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 OCTYLDODECYL STEARATE INACTIVE INGREDIENT K6F16QGO28 CLOTRIMAZOLE CREAM [STAT RX USA LLC] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CLOTRIMAZOLE CREAM [STAT RX USA LLC] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X CLOTRIMAZOLE CREAM [STAT RX USA LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CLOTRIMAZOLE CREAM [STAT RX USA LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1275 CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 8 package rows 20241222_77883cfd-f13c-40cb-88b2-8f777e1cdce9.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 Units Marketing start Marketing end Sample Exclude flag Status 51672-1275-1 51672127501 1 TUBE in 1 CARTON (51672-1275-1) / 15 g in 1 TUBE 1 tube 1993-08-31 0000-00-00 No No Current 51672-1275-2 51672127502 1 TUBE in 1 CARTON (51672-1275-2) / 30 g in 1 TUBE 1 tube 1993-08-31 0000-00-00 No No Current 51672-1275-6 51672127506 1 TUBE in 1 CARTON (51672-1275-6) / 45 g in 1 TUBE 1 tube 1993-08-31 0000-00-00 No No Current 51672-1275-7 51672127507 2 TUBE in 1 CARTON (51672-1275-7) / 45 g in 1 TUBE 2 tube 1993-08-31 0000-00-00 No No Current