FDA.reportPublic FDA data

Tazarotene

Product NDC
73473-310
11-digit product format
734730310
Labeler code
73473
Product ID
73473-310_d0c2fbdf-c1f1-43de-93ef-7da5e6279875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tazarotene
Dosage form
GEL
Route
CUTANEOUS
Labeler
Solaris Pharma Corporation
Application
ANDA213644
Marketing category
ANDA
Marketing start
2025-01-03
Substance
TAZAROTENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tazarotene
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAZAROTENE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii81BDR9Y8PS
Rxcui313199, 313201

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
5993ea1b-833d-fa4b-caad-a0d477537538Product name520250305
c24b0f4e-b27e-8e2b-a129-1b5a6d72c459Product name220231128
18da2240-e326-4d63-90cd-d6bb15f662a0Product name120200604
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73473-310-10Tazarotene100 g in 1 TUBEGEL1004
73473-310-10Tazarotene1 in 1 CARTONGEL14
73473-310-30Tazarotene30 g in 1 TUBEGEL304
73473-310-30Tazarotene1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73473-310TAZAROTENE GEL [SOLARIS PHARMA CORPORATION]4Current NDC, 4 package rows20250104_f1c98c4a-f101-4f3c-851a-39c827415c46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313199tazarotene 0.05 % Topical GelPSNf1c98c4a-f101-4f3c-851a-39c827415c464
313201tazarotene 0.1 % Topical GelPSNf1c98c4a-f101-4f3c-851a-39c827415c464
313199tazarotene 0.0005 MG/MG Topical GelSCDf1c98c4a-f101-4f3c-851a-39c827415c464
313201tazarotene 0.001 MG/MG Topical GelSCDf1c98c4a-f101-4f3c-851a-39c827415c464
313199tazarotene 0.05 % Topical GelSYf1c98c4a-f101-4f3c-851a-39c827415c464
313201tazarotene 0.1 % Topical GelSYf1c98c4a-f101-4f3c-851a-39c827415c464

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73473-310-10734730310101 TUBE in 1 CARTON (73473-310-10) / 100 g in 1 TUBE1 tube2025-01-03NoNoHistorical
73473-310-30734730310301 TUBE in 1 CARTON (73473-310-30) / 30 g in 1 TUBE1 tube2025-01-03NoNoHistorical