Home NDC 62135-814 Ciclopirox
Product NDC 62135-814
11-digit product format 621350814
Labeler code 62135
Product ID 62135-814_41b5be9e-4f27-f7aa-e063-6394a90a00d8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciclopirox
Dosage form SOLUTION
Route TOPICAL
Labeler Chartwell RX, LLC
Application ANDA078046
Marketing category ANDA
Marketing start 2007-09-18
Substance CICLOPIROX
Active strength 71.3 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 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product 62135-814 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62135-814 62135-814-45 I Inactivated by FDA excluded / ndc_excluded.zip 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 A078046-001 CICLOPIROX CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078046-001 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 · 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 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078046-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 71.3 mg/mL
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 62135-814-45 Ciclopirox 6.6 mL in 1 BOTTLE SOLUTION 6.6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-814 CICLOPIROX SOLUTION [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20240405_8ce98020-5615-4332-bf57-72777e2ce038.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-814-45 62135081445 6.6 mL in 1 BOTTLE (62135-814-45) 6.6 ml 2024-03-28 No No Current