Home NDC 51672-1351-8 Ciclopirox
Product NDC 51672-1351
Requested package NDC 51672-1351-8
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.
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 2026-08-01 22:54:32 2026-06 A090269-001 CICLOPIROX 1% SHAMPOO / TOPICAL AT 2011-02-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A090269-001 AT 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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