FDA.reportPublic FDA data

TAZAROTENE

Product NDC
0713-0804
11-digit product format
007130804
Labeler code
0713
Product ID
0713-0804_0b4b0b29-a411-44a4-e063-6294a90ab3ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tazarotene
Dosage form
GEL
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA214136
Marketing category
ANDA
Marketing start
2022-09-14
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
Rxcui313201

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
5993ea1b-833d-fa4b-caad-a0d477537538Product name520250305
c24b0f4e-b27e-8e2b-a129-1b5a6d72c459Product name220231128
18da2240-e326-4d63-90cd-d6bb15f662a0Product name120200604
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0804-31TAZAROTENE1 in 1 CARTONGEL12
0713-0804-31TAZAROTENE30 g in 1 TUBEGEL302
0713-0804-99TAZAROTENE100 g in 1 TUBEGEL1002
0713-0804-99TAZAROTENE1 in 1 CARTONGEL12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0804-31GM - Gram0713-0804b64bbc28-9370-4f45-ae32-27d5c83a9f3612022-10-06
0713-0804-99GM - Gram0713-0804501a3562-5854-4284-a15e-780a7e02655f12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0804TAZAROTENE GEL [COSETTE PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 4 package rows20231130_94749b8e-0d00-4257-a660-6d0fc8815fcf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313201tazarotene 0.1 % Topical GelPSN94749b8e-0d00-4257-a660-6d0fc8815fcf2
313201tazarotene 0.001 MG/MG Topical GelSCD94749b8e-0d00-4257-a660-6d0fc8815fcf2
313201tazarotene 0.1 % Topical GelSY94749b8e-0d00-4257-a660-6d0fc8815fcf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0804-31007130804311 TUBE in 1 CARTON (0713-0804-31) / 30 g in 1 TUBE1 tube2022-09-140000-00-00NoNoCurrent
0713-0804-99007130804991 TUBE in 1 CARTON (0713-0804-99) / 100 g in 1 TUBE1 tube2022-09-140000-00-00NoNoCurrent