Home NDC 82568-0036 CLOTRIMAZOLE
Product NDC 82568-0036
11-digit product format 825680036
Labeler code 82568
Product ID 82568-0036_4bd825f4-f5e3-aab7-e063-6394a90ad6a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLOTRIMAZOLE
Dosage form SPRAY
Route TOPICAL
Labeler AARNA USA INC
Application ANDA216569
Marketing category ANDA
Marketing start 2023-10-16
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 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 A216569-001 CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216569-001 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.
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 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216569-001 CLOTRIMAZOLE 1% SOLUTION / TOPICAL AT 2023-10-16 a50c72e98297…
Observed Orange Book normalized TE history# 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/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 358371 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# 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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clotrimazole Topical Solution USP, 1% CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% ScieGen Pharmaceuticals, Inc 15368c2a-572f-41fb-a3a1-7b1eb842faa8 2026-04-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216569 application number: ANDA216569 Clotrimazole Topical Solution USP, 1% CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% Allegis Holdings, LLC 529bb597-b291-42fb-b45f-744a55df64f1 2026-04-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216569 application number: ANDA216569 CLOTRIMAZOLE CLOTRIMAZOLE AARNA USA INC 4bd825f4-f5e2-aab7-e063-6394a90ad6a4 2026-02-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216569 application number: ANDA216569 ndc (product): 82568-0036 Clotrimazole Topical Solution USP, 1% CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% Akron Pharma Inc. 32b968ce-e112-441c-a91f-c62f2f67b57c 2024-10-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216569 application number: ANDA216569
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82568-0036-1 82568003601 1 BOTTLE in 1 CARTON (82568-0036-1) / 10 mL in 1 BOTTLE 1 bottle 2023-10-16 No No Current 82568-0036-3 82568003603 1 BOTTLE in 1 CARTON (82568-0036-3) / 30 mL in 1 BOTTLE 1 bottle 2023-10-16 No No Current 82568-0036-6 82568003606 2 BOTTLE in 1 CARTON (82568-0036-6) / 30 mL in 1 BOTTLE 2 bottle 2024-03-09 No No Current