Home NDC 67296-2252-1 Clotrimazole
Product NDC 67296-2252
Requested package NDC 67296-2252-1
11-digit product format 672962252
Labeler code 67296
Product ID 67296-2252_5f6f8bb6-7b39-448a-e063-6394a90a8cb6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler Redpharm Drug
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 · 45 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 2026-11-14 07:37:17 2026-10 A090219-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2010-08-03 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A090219-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2010-08-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090219-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2010-08-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090219-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2010-08-03 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
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/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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67296-2252-1 67296225201 15 g in 1 TUBE (67296-2252-1) 15 g 2010-08-04 No No Current