Home NDC 50090-7343 Clotrimazole
Product NDC 50090-7343
11-digit product format 500907343
Labeler code 50090
Product ID 50090-7343_4774f542-49de-4b7e-b301-f8c969e0aca1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler A-S Medication Solutions
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-7343-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-7343-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-7343-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-7343-0 ad56d346431e…cc804d4bbf1e…
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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A090219-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2010-08-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090219-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2010-08-03 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-7343-0 Clotrimazole 30 g in 1 TUBE CREAM 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-7343 CLOTRIMAZOLE CREAM [A-S MEDICATION SOLUTIONS] 5 Current NDC, 1 package rows 20250209_116be3a8-9a57-4b4a-a873-98a4ce83bcf7.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-7343-0 50090734300 30 g in 1 TUBE (50090-7343-0) 30 g 2024-10-16 No No Current