tazarotene

Generic: tazarotene

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tazarotene
Generic Name tazarotene
Labeler cosette pharmaceuticals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

tazarotene .5 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0805
Product ID 0713-0805_0b4ad65c-1d55-3e68-e063-6294a90a8e54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215433
Listing Expiration 2026-12-31
Marketing Start 2022-09-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130805
Hyphenated Format 0713-0805

Supplemental Identifiers

RxCUI
313199
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 ANDA215433 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0713-0805-31) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0805-99) / 100 g in 1 TUBE
source: ndc

Packages (2)

Ingredients (1)

tazarotene (.5 mg/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "0b4ad65c-1d55-3e68-e063-6294a90a8e54", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["81BDR9Y8PS"], "rxcui": ["313199"], "spl_set_id": ["ecd718fd-c06e-4b3a-8aca-fa51e7c51a66"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0713-0805-31)  / 30 g in 1 TUBE", "package_ndc": "0713-0805-31", "marketing_start_date": "20220914"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0805-99)  / 100 g in 1 TUBE", "package_ndc": "0713-0805-99", "marketing_start_date": "20220914"}], "brand_name": "TAZAROTENE", "product_id": "0713-0805_0b4ad65c-1d55-3e68-e063-6294a90a8e54", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0713-0805", "generic_name": "tazarotene", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TAZAROTENE", "active_ingredients": [{"name": "TAZAROTENE", "strength": ".5 mg/g"}], "application_number": "ANDA215433", "marketing_category": "ANDA", "marketing_start_date": "20220914", "listing_expiration_date": "20261231"}