Home NDC 51672-1351 Ciclopirox
Product NDC 51672-1351
11-digit product format 516721351
Labeler code 51672
Product ID 51672-1351_39620da3-e63e-e94f-e063-6294a90afd69
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciclopirox
Dosage form SHAMPOO
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA090269
Marketing category ANDA
Marketing start 2011-02-23
Substance CICLOPIROX
Active strength 10 mg/.96mL
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 A090269-001 CICLOPIROX CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090269-001 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 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 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 10 mg/.96mL
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1351-8 Ciclopirox 1 in 1 CARTON SHAMPOO 1 8 51672-1351-8 Ciclopirox 120 mL in 1 BOTTLE, PLASTIC SHAMPOO 120 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1351 CICLOPIROX SHAMPOO [TARO PHARMACEUTICALS U.S.A., INC.] 7 Current NDC, Legacy NDC, 2 package rows 20241222_b44b190b-8e2a-4937-a6c5-92f37911e7f8.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 Marketing start Marketing end Sample Exclude flag Status 51672-1351-8 51672135108 1 BOTTLE, PLASTIC in 1 CARTON (51672-1351-8) / 120 mL in 1 BOTTLE, PLASTIC 2011-02-23 0000-00-00 No No Current