Home NDC 71205-432 Clotrimazole
Product NDC 71205-432
11-digit product format 712050432
Labeler code 71205
Product ID 71205-432_64950943-266b-4fe5-bfc0-643875330c13
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler Proficient Rx LP
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 42 .
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 · 42 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 2026-08-18 06:07:40 2026-07 A072640-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB RS 1993-08-31 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71205-432-15 Clotrimazole 1 in 1 CARTON CREAM 1 2 71205-432-15 Clotrimazole 15 g in 1 TUBE CREAM 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-432 CLOTRIMAZOLE CREAM [PROFICIENT RX LP] 2 Current NDC, Legacy NDC, 2 package rows 20230222_c62264a9-cea3-4461-9399-35d8931d38d5.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 71205-432-15 71205043215 1 TUBE in 1 CARTON (71205-432-15) / 15 g in 1 TUBE 1 tube 2020-03-18 0000-00-00 No No Current