FDA.reportPublic FDA data

TAZAROTENE

Product NDC
45802-706
11-digit product format
458020706
Labeler code
45802
Product ID
45802-706_27ddf7ba-f3a2-43ff-83a5-e7c95b355028
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tazarotene
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA217075
Marketing category
ANDA
Marketing start
2024-09-09
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
Rxcui314268

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
45802-706-94TAZAROTENE30 g in 1 TUBECREAM302
45802-706-94TAZAROTENE1 in 1 CARTONCREAM12
45802-706-96TAZAROTENE60 g in 1 TUBECREAM602
45802-706-96TAZAROTENE1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-706-94GM - Gram45802-706b2baf252-eac0-4255-83f3-bbbef1c0fd6212024-10-04
45802-706-96GM - Gram45802-7065ac8b924-93c5-42aa-a6cb-d9ad55f1155a12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-706TAZAROTENE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]2Current NDC, 4 package rows20240910_df5d65de-0693-4fd2-b335-f04ab1e201e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314268tazarotene 0.05 % Topical CreamPSN91264c0a-223c-47b7-b537-071944f25790100
314268tazarotene 0.5 MG/ML Topical CreamSCD91264c0a-223c-47b7-b537-071944f25790100
314268tazarotene 0.05 % Topical CreamSY91264c0a-223c-47b7-b537-071944f25790100
314268tazarotene 0.05 % Topical CreamPSNdf5d65de-0693-4fd2-b335-f04ab1e201e72
314268tazarotene 0.5 MG/ML Topical CreamSCDdf5d65de-0693-4fd2-b335-f04ab1e201e72
314268tazarotene 0.05 % Topical CreamSYdf5d65de-0693-4fd2-b335-f04ab1e201e72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
45802-706-94458020706941 TUBE in 1 CARTON (45802-706-94) / 30 g in 1 TUBE1 tube2024-09-09NoNoHistorical
45802-706-96458020706961 TUBE in 1 CARTON (45802-706-96) / 60 g in 1 TUBE1 tube2024-09-09NoNoHistorical