FDA.reportPublic FDA data

Tazarotene

Product NDC
0713-0765
11-digit product format
007130765
Labeler code
0713
Product ID
0713-0765_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
2025-03-10
Substance
TAZAROTENE
Active strength
.5 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
TAZAROTENE.5 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
0713-0765-31Tazarotene1 in 1 CARTONCREAM18
0713-0765-31Tazarotene30 g in 1 TUBECREAM308
0713-0765-60Tazarotene1 in 1 CARTONCREAM18
0713-0765-60Tazarotene60 g in 1 TUBECREAM608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0765-31GM - Gram0713-0765abb12cf4-e667-4a45-b24e-dceaf6f5276012025-05-14
0713-0765-60GM - Gram0713-0765bacc7bd5-ea59-4516-b4a5-64d61624fee712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0765TAZAROTENE CREAM [COSETTE PHARMACEUTICALS, INC.]8Current 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 startSampleExclude flagStatus
0713-0765-31007130765311 TUBE in 1 CARTON (0713-0765-31) / 30 g in 1 TUBE1 tube2025-03-10NoNoCurrent
0713-0765-60007130765601 TUBE in 1 CARTON (0713-0765-60) / 60 g in 1 TUBE1 tube2025-03-10NoNoCurrent