Home NDC 0168-0133-15 Clotrimazole
Product NDC 0168-0133
Requested package NDC 0168-0133-15
11-digit product format 001680133
Labeler code 0168
Product ID 0168-0133_41af1c38-dbb2-46ac-94da-64e4639825c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application ANDA078338
Marketing category ANDA
Marketing start 2008-09-02
Marketing end 0000-00-00
Substance CLOTRIMAZOLE
Active strength 10 mg/g
Pharmacologic classes Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078338-001 CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078338-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078338-001 CLOTRIMAZOLE 1% CREAM / TOPICAL AB 2008-09-02 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0168-0133-15 Clotrimazole 15 g in 1 TUBE CREAM 15 7 0168-0133-30 Clotrimazole 30 g in 1 TUBE CREAM 30 7 0168-0133-46 Clotrimazole 45 g in 1 TUBE CREAM 45 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOTRIMAZOLE ACTIVE INGREDIENT G07GZ97H65 CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 CLOTRIMAZOLE ACTIVE MOIETY G07GZ97H65 CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 CETYL ESTERS WAX INACTIVE INGREDIENT D072FFP9GU CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 OCTYLDODECANOL INACTIVE INGREDIENT 461N1O614Y CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0133 CLOTRIMAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Legacy NDC, 3 package rows 20200916_28fdc2c0-fd5f-4d98-a4e1-4702a430086a.zip
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 0168-0133-15 00168013315 15 g in 1 TUBE (0168-0133-15) 15 g 2008-09-02 0000-00-00 No No Current