tazarotene

Generic: tazarotene

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tazarotene
Generic Name tazarotene
Labeler padagis israel pharmaceuticals ltd
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

tazarotene 1 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-442
Product ID 45802-442_710d0db0-54af-49fd-b2ed-77582a4b3238
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213079
Listing Expiration 2026-12-31
Marketing Start 2023-06-05

Pharmacologic Class

Established (EPC)
retinoid [epc]
Chemical Structure
retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802442
Hyphenated Format 45802-442

Supplemental Identifiers

RxCUI
313199 313201
UNII
81BDR9Y8PS
NUI
N0000175607 M0018962

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tazarotene (source: ndc)
Generic Name tazarotene (source: ndc)
Application Number ANDA213079 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-442-01) / 100 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-442-94) / 30 g in 1 TUBE
source: ndc

Packages (2)

45802-442-01 1 TUBE in 1 CARTON (45802-442-01) / 100 g in 1 TUBE 45802-442-94 1 TUBE in 1 CARTON (45802-442-94) / 30 g in 1 TUBE

Ingredients (1)

tazarotene (1 mg/g)

Linked Drug Pages (1)

TAZAROTENE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "710d0db0-54af-49fd-b2ed-77582a4b3238", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["81BDR9Y8PS"], "rxcui": ["313199", "313201"], "spl_set_id": ["ffd11dee-4266-4201-9573-1e82c2d30a63"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-442-01)  / 100 g in 1 TUBE", "package_ndc": "45802-442-01", "marketing_start_date": "20230605"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-442-94)  / 30 g in 1 TUBE", "package_ndc": "45802-442-94", "marketing_start_date": "20230605"}], "brand_name": "TAZAROTENE", "product_id": "45802-442_710d0db0-54af-49fd-b2ed-77582a4b3238", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "45802-442", "generic_name": "tazarotene", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TAZAROTENE", "active_ingredients": [{"name": "TAZAROTENE", "strength": "1 mg/g"}], "application_number": "ANDA213079", "marketing_category": "ANDA", "marketing_start_date": "20230605", "listing_expiration_date": "20261231"}