Home NDC 21922-105 CICLOPIROX
Product NDC 21922-105
11-digit product format 219220105
Labeler code 21922
Product ID 21922-105_1b7b23aa-fc6d-4b37-b5db-7fd7bc994bf3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciclopirox
Dosage form SHAMPOO
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA209975
Marketing category ANDA
Marketing start 2025-12-03
Substance CICLOPIROX
Active strength 1 g/100mL
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 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 A209975-001 CICLOPIROX CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209975-001 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 · 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 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL 2018-04-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209975-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2018-04-05 cb3db0bc1861…
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 1 g/100mL
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 250344 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 21922-105-52 CICLOPIROX 120 mL in 1 BOTTLE SHAMPOO 120 1 21922-105-52 CICLOPIROX 1 in 1 CARTON SHAMPOO 1 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 21922-105-52 21922010552 1 BOTTLE in 1 CARTON (21922-105-52) / 120 mL in 1 BOTTLE 1 bottle 2025-12-03 No No Current