FDA.reportPublic FDA data

Ciclopirox

Product NDC
0168-0407
11-digit product format
001680407
Labeler code
0168
Product ID
0168-0407_0c2acee6-0de3-4a80-9483-c45c8506e504
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
GEL
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA077896
Marketing category
ANDA
Marketing start
2008-06-10
Marketing end
0000-00-00
Substance
CICLOPIROX
Active strength
8 mg/g
Pharmacologic classes
Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0168-0407IInactivated by FDA2026-07-31
excluded packagepackage0168-04070168-0407-30IInactivated by FDA2026-07-31
excluded packagepackage0168-04070168-0407-46IInactivated by FDA2026-07-31
excluded packagepackage0168-04070168-0407-99IInactivated by FDA2026-07-31

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
A077896-001CICLOPIROXCICLOPIROX0.77%GEL / TOPICALAB2008-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077896-001AB

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 22:54:322026-06A077896-001CICLOPIROX0.77%GEL / TOPICALAB2008-06-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077896-001AB1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d24c6245-86b5-4444-bc75-c1ac73ab3016Product name120180612
c7015f08-288e-4cfa-93b5-f4959a4814aeProduct name120150324
3f974526-143f-9d19-ee0c-98eeee0cdc3fProduct name120140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0407-302020-01-31C16284748780-19d75b9d0-f6a6-f424-e053-dadaa90a57ceCICLOPIROX GEL 0.77%
0168-0407-462020-01-31C16284748780-19d75b9d0-f6a6-f424-e053-dadaa90a57ceCICLOPIROX GEL 0.77%
0168-0407-992020-01-31C16284748780-19d75b9d0-f6a6-f424-e053-dadaa90a57ceCICLOPIROX GEL 0.77%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0407-30Ciclopirox30 g in 1 TUBEGEL306
0168-0407-46Ciclopirox45 g in 1 TUBEGEL456
0168-0407-99Ciclopirox100 g in 1 TUBEGEL1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0407-30GM - Gram0168-04074fb7c745-7889-4841-a247-8fd3448efda412012-07-24
0168-0407-46GM - Gram0168-0407b574a866-ebfb-4e34-85ff-3beceee1577c12013-02-13
0168-0407-99GM - Gram0168-0407a3b16523-549b-4237-9d19-ad9f8899027e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CICLOPIROXACTIVE INGREDIENT19W019ZDRJCICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
CICLOPIROXACTIVE MOIETY19W019ZDRJCICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ECICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YCICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
PEG/PPG-18/18 DIMETHICONEINACTIVE INGREDIENT9H0AO7T794CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RCICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0407CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6Legacy NDC, 3 package rows20150729_88324009-d5cc-4982-be3e-058e0436f608.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313941ciclopirox 0.77 % Topical GelPSN88324009-d5cc-4982-be3e-058e0436f6086
313941ciclopirox 0.0077 MG/MG Topical GelSCD88324009-d5cc-4982-be3e-058e0436f6086
313941ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical GelSY88324009-d5cc-4982-be3e-058e0436f6086
313941ciclopirox 0.77 % Topical GelSY88324009-d5cc-4982-be3e-058e0436f6086

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0168-0407-300016804073030 g in 1 TUBE30 gHistorical
0168-0407-460016804074645 g in 1 TUBE45 gHistorical
0168-0407-9900168040799100 g in 1 TUBE100 gHistorical