FDA.reportPublic FDA data

Tazarotene Cream

Product NDC
0168-0455
Requested package NDC
0168-0455-30
11-digit product format
001680455
Labeler code
0168
Product ID
0168-0455_0379f694-2a2b-40ba-bb7b-f889b11cbefe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tazarotene
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA211175
Marketing category
ANDA
Marketing start
2019-01-28
Marketing end
0000-00-00
Substance
TAZAROTENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC],Retinoids [CS]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0168-04550168-0455-30DDiscontinued 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
A211175-001TAZAROTENETAZAROTENE0.1%CREAM / TOPICAL2019-01-28

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 22:54:322026-06A211175-001TAZAROTENE0.1%CREAM / TOPICAL2019-01-28a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0455-302024-07-11C16284748780-1ab0e2407-2a76-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997
0168-0455-302021-07-23C16284748780-1ab0e2407-2a76-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997
0168-0455-302020-09-17C16284748780-1ab0e2407-2a76-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997
0168-0455-302020-07-22C16284748780-1ab0e2407-2a76-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0455-30001680455301 TUBE in 1 CARTON (0168-0455-30) > 30 g in 1 TUBE1 tube2019-01-280000-00-00NoNoCurrent