Home NDC 68788-8755 CICLOPIROX
Product NDC 68788-8755
11-digit product format 687888755
Labeler code 68788
Product ID 68788-8755_d3c4c98c-1054-4e76-b9b6-1bc37acbbc72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciclopirox
Dosage form SOLUTION
Route TOPICAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA077687
Marketing category ANDA
Marketing start 2024-10-14
Substance CICLOPIROX
Active strength 80 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 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 A077687-001 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 A077687-001 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 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL AT 2007-09-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077687-001 CICLOPIROX 8% SOLUTION / TOPICAL 2007-09-18 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base CICLOPIROX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CICLOPIROX 80 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309291 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 68788-8755-6 CICLOPIROX 1 in 1 CARTON SOLUTION 1 2 68788-8755-6 CICLOPIROX 6.6 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION 6.6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8755 CICLOPIROX SOLUTION [PREFERRED PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20241016_eb7b7163-2ee7-447a-b585-7a240070f84b.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68788-8755-6 68788875506 1 BOTTLE, WITH APPLICATOR in 1 CARTON (68788-8755-6) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR 2024-10-14 No No Current