Home NDC 71335-2757 ciclopirox
Product NDC 71335-2757
11-digit product format 713352757
Labeler code 71335
Product ID 71335-2757_f12c1396-d3e6-46a4-b8b3-2cf17dc17f06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciclopirox
Dosage form GEL
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA091595
Marketing category ANDA
Marketing start 2012-02-29
Substance CICLOPIROX
Active strength 7.7 mg/g
Pharmacologic classes Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A091595-001 CICLOPIROX CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091595-001 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 · 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 2026-02-19 14:30 UTC 2026-02 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB RS 2012-02-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091595-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2012-02-29 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 ciclopirox
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CICLOPIROX 7.7 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 19W019ZDRJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313941 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 71335-2757-1 ciclopirox 30 g in 1 TUBE GEL 30 100
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 Sample Exclude flag Status 71335-2757-1 71335275701 30 g in 1 TUBE (71335-2757-1) 30 g 2025-08-08 No No Current