Home NDC 51672-1323 Ciclopirox
Product NDC 51672-1323
11-digit product format 516721323
Labeler code 51672
Product ID 51672-1323_25819de3-29fb-421e-ba38-0f933499c4ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciclopirox
Dosage form SUSPENSION
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA077092
Marketing category ANDA
Marketing start 2005-08-10
Marketing end 0000-00-00
Substance CICLOPIROX OLAMINE
Active strength 8 mg/mL
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 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51672-1323-4 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51672-1323-3 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51672-1323-4 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51672-1323-3 f5e01cc5f278…a2eaf40c39c3…
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 A077092-001 CICLOPIROX CICLOPIROX 0.77% SUSPENSION / TOPICAL 2005-08-10
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 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL 2005-08-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL 2005-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL 2005-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077092-001 CICLOPIROX 0.77% SUSPENSION / TOPICAL AB 2005-08-10 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ciclopirox Olamine ACTIVE INGREDIENT 50MD4SB4AP CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Ciclopirox ACTIVE MOIETY 19W019ZDRJ CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 coco diethanolamide INACTIVE INGREDIENT 92005F972D CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 lactic acid INACTIVE INGREDIENT 33X04XA5AT CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 mineral oil INACTIVE INGREDIENT T5L8T28FGP CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 myristyl alcohol INACTIVE INGREDIENT V42034O9PU CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 octyldodecanol INACTIVE INGREDIENT 461N1O614Y CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1323 CICLOPIROX SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 4 Legacy NDC 20241222_ba17b0e0-08dc-47b5-ae10-4d4e5123161d.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-1323-3 51672132303 1 BOTTLE in 1 CARTON (51672-1323-3) > 30 mL in 1 BOTTLE 1 bottle 2005-08-10 0000-00-00 No No Current 51672-1323-4 51672132304 1 BOTTLE in 1 CARTON (51672-1323-4) > 60 mL in 1 BOTTLE 1 bottle 2005-08-10 0000-00-00 No No Current