Home NDC 52817-800 Clotrimazole Topical Solution USP, 1%
Product NDC 52817-800
11-digit product format 528170800
Labeler code 52817
Product ID 52817-800_48ab26b2-908a-43d1-e063-6394a90a2cb5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clotrimazole Topical Solution USP, 1%
Dosage form SOLUTION
Route TOPICAL
Labeler TruPharma LLC
Application ANDA212281
Marketing category ANDA
Marketing start 2019-07-25
Substance CLOTRIMAZOLE
Active strength 10 mg/mL
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 A212281-001 CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212281-001 AT
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 2026-08-18 06:07:40 2026-07 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212281-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2019-07-25 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 Topical Solution USP, 1%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 10 mg/mL
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 309370 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 52817-800-30 Clotrimazole Topical Solution USP, 1% 1 in 1 CARTON SOLUTION 1 5 52817-800-30 Clotrimazole Topical Solution USP, 1% 30 mL in 1 BOTTLE SOLUTION 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52817-800 CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% SOLUTION [TRUPHARMA LLC] 3 Current NDC, Legacy NDC, 2 package rows 20231229_1d2354f2-edfd-4be7-9550-760958eb36ee.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 52817-800-30 52817080030 1 BOTTLE in 1 CARTON (52817-800-30) / 30 mL in 1 BOTTLE 1 bottle 2019-07-25 0000-00-00 No No Current