Home NDC 68462-181 Clotrimazole
Product NDC 68462-181
11-digit product format 684620181
Labeler code 68462
Product ID 68462-181_23d83b26-b5da-4474-9468-4909134295d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
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 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 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 · 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 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…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…
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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-181-17 Clotrimazole 15 g in 1 TUBE CREAM 15 8 68462-181-35 Clotrimazole 30 g in 1 TUBE CREAM 30 8 68462-181-47 Clotrimazole 45 g in 1 TUBE CREAM 45 8 68462-181-48 Clotrimazole 2 in 1 CARTON CREAM 2 8 68462-181-48 Clotrimazole 45 g in 1 TUBE CREAM 45 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOTRIMAZOLE ACTIVE INGREDIENT G07GZ97H65 CLOTRIMAZOLE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 6 CLOTRIMAZOLE ACTIVE MOIETY G07GZ97H65 CLOTRIMAZOLE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 6 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CLOTRIMAZOLE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 6 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CLOTRIMAZOLE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 6 OCTYLDODECANOL INACTIVE INGREDIENT 461N1O614Y CLOTRIMAZOLE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 6 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CLOTRIMAZOLE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 6 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU CLOTRIMAZOLE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 6 WATER INACTIVE INGREDIENT 059QF0KO0R CLOTRIMAZOLE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-181 CLOTRIMAZOLE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 7 Current NDC, Legacy NDC, 5 package rows 20181212_f6898117-14f3-42d2-bc0e-d296add3ad70.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 Marketing end Sample Exclude flag Status 68462-181-17 68462018117 15 g in 1 TUBE (68462-181-17) 15 g 2010-08-04 0000-00-00 No No Current 68462-181-35 68462018135 30 g in 1 TUBE (68462-181-35) 30 g 2010-08-04 0000-00-00 No No Current 68462-181-47 68462018147 45 g in 1 TUBE (68462-181-47) 45 g 2010-08-04 0000-00-00 No No Current 68462-181-48 68462018148 2 TUBE in 1 CARTON (68462-181-48) / 45 g in 1 TUBE 2 tube 2010-08-04 0000-00-00 No No Current