FDA.reportPublic FDA data

Tazarotene

Product NDC
0713-0670
11-digit product format
007130670
Labeler code
0713
Product ID
0713-0670_3001f737-a4db-b824-e063-6294a90a784e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tazarotene
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA208662
Marketing category
ANDA
Marketing start
2017-12-22
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
Rxcui313200, 314268

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
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0670-31Tazarotene1 in 1 CARTONCREAM18
0713-0670-31Tazarotene30 g in 1 TUBECREAM308
0713-0670-60Tazarotene1 in 1 CARTONCREAM18
0713-0670-60Tazarotene60 g in 1 TUBECREAM608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0670-31GM - Gram0713-0670ae5903d0-ec8e-4b52-b62d-72a16a6f94c212018-01-12
0713-0670-60GM - Gram0713-0670ec2d4c6a-1c86-4cb8-bb3d-671339b4e52212018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0670TAZAROTENE CREAM [COSETTE PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 4 package rows20250312_fa5caf83-29d5-8229-b125-d7736928f132.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314268tazarotene 0.05 % Topical CreamPSNfa5caf83-29d5-8229-b125-d7736928f1328
313200tazarotene 0.1 % Topical CreamPSNfa5caf83-29d5-8229-b125-d7736928f1328
314268tazarotene 0.5 MG/ML Topical CreamSCDfa5caf83-29d5-8229-b125-d7736928f1328
313200tazarotene 1 MG/ML Topical CreamSCDfa5caf83-29d5-8229-b125-d7736928f1328
314268tazarotene 0.05 % Topical CreamSYfa5caf83-29d5-8229-b125-d7736928f1328
313200tazarotene 0.1 % Topical CreamSYfa5caf83-29d5-8229-b125-d7736928f1328

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0670-31007130670311 TUBE in 1 CARTON (0713-0670-31) / 30 g in 1 TUBE1 tube2017-12-220000-00-00NoNoCurrent
0713-0670-60007130670601 TUBE in 1 CARTON (0713-0670-60) / 60 g in 1 TUBE1 tube2017-12-220000-00-00NoNoCurrent