FDA.reportPublic FDA data

TAZAROTENE

Product NDC
45802-436
11-digit product format
458020436
Labeler code
45802
Product ID
45802-436_710d0db0-54af-49fd-b2ed-77582a4b3238
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tazarotene
Dosage form
GEL
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA213079
Marketing category
ANDA
Marketing start
2023-06-05
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
Rxcui313199, 313201

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
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-436-01TAZAROTENE1 in 1 CARTONGEL13
45802-436-01TAZAROTENE100 g in 1 TUBEGEL1003
45802-436-94TAZAROTENE1 in 1 CARTONGEL13
45802-436-94TAZAROTENE30 g in 1 TUBEGEL303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-436-01GM - Gram45802-4366fecac76-e0ef-4c27-9ab7-397f7704a10312023-07-06
45802-436-94GM - Gram45802-4363eaa20ba-1f3c-4cbe-b750-5b6b47d69f0012023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-436TAZAROTENE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]3Current NDC, 4 package rows20240518_ffd11dee-4266-4201-9573-1e82c2d30a63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313199tazarotene 0.05 % Topical GelPSNffd11dee-4266-4201-9573-1e82c2d30a633
313201tazarotene 0.1 % Topical GelPSNffd11dee-4266-4201-9573-1e82c2d30a633
313199tazarotene 0.0005 MG/MG Topical GelSCDffd11dee-4266-4201-9573-1e82c2d30a633
313201tazarotene 0.001 MG/MG Topical GelSCDffd11dee-4266-4201-9573-1e82c2d30a633
313199tazarotene 0.05 % Topical GelSYffd11dee-4266-4201-9573-1e82c2d30a633
313201tazarotene 0.1 % Topical GelSYffd11dee-4266-4201-9573-1e82c2d30a633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
45802-436-01458020436011 TUBE in 1 CARTON (45802-436-01) / 100 g in 1 TUBE1 tube2023-06-05NoNoHistorical
45802-436-94458020436941 TUBE in 1 CARTON (45802-436-94) / 30 g in 1 TUBE1 tube2023-06-05NoNoHistorical