FDA.reportPublic FDA data

Ciclopirox

Product NDC
0168-0449
11-digit product format
001680449
Labeler code
0168
Product ID
0168-0449_710704bb-c966-436e-962e-1c317c27269f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Fougera Pharmaceuticals Inc.
Application
ANDA090146
Marketing category
ANDA
Marketing start
2010-05-25
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0168-0449DDiscontinued by firm2026-07-31
excluded packagepackage0168-04490168-0449-04DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090146-001CICLOPIROXCICLOPIROX1%SHAMPOO / TOPICALAT2010-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090146-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090146-001CICLOPIROX1%SHAMPOO / TOPICALAT2010-05-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090146-001AT1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0449-042020-09-18C16284748780-19d75b9d0-e659-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CICLOPIROX Shampoo safely and effectively. See full prescribing information for CICLOPIROX Shampoo. CICLOPIROX Shampoo 1% for topical use Initial U.S. Approval: 1982
0168-0449-042020-01-31C16284748780-19d75b9d0-e659-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CICLOPIROX Shampoo safely and effectively. See full prescribing information for CICLOPIROX Shampoo. CICLOPIROX Shampoo 1% for topical use Initial U.S. Approval: 1982

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciclopiroxACTIVE INGREDIENT19W019ZDRJCICLOPIROX SHAMPOO [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
ciclopiroxACTIVE MOIETY19W019ZDRJCICLOPIROX SHAMPOO [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
disodium laureth sulfosuccinateINACTIVE INGREDIENTD6DH1DTN7ECICLOPIROX SHAMPOO [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
laureth-2INACTIVE INGREDIENTD4D38LT1L5CICLOPIROX SHAMPOO [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
sodium chlorideINACTIVE INGREDIENT451W47IQ8XCICLOPIROX SHAMPOO [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
sodium laureth sulfateINACTIVE INGREDIENTBPV390UAP0CICLOPIROX SHAMPOO [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
waterINACTIVE INGREDIENT059QF0KO0RCICLOPIROX SHAMPOO [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0449-04001680449041 BOTTLE in 1 CARTON (0168-0449-04) > 120 mL in 1 BOTTLE1 bottle2010-05-250000-00-00NoNoCurrent