adapalene and benzoyl peroxide (72578-119)

Drug Facts

Product Profile

Brand Name adapalene and benzoyl peroxide

Generic Name adapalene and benzoyl peroxide

Labeler viona pharmaceuticals inc

Dosage Form GEL

Routes

TOPICAL

Active Ingredients

adapalene 3 mg/g, benzoyl peroxide 25 mg/g

Manufacturer

Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-119

Product ID 72578-119_edefb257-b872-45cb-a882-fa6991d6cb57

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214553

Listing Expiration 2026-12-31

Marketing Start 2022-06-06

Pharmacologic Class

Established (EPC)

retinoid [epc]

Chemical Structure

retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578119

Hyphenated Format 72578-119

Supplemental Identifiers

RxCUI

1663745

UNII

1L4806J2QF W9WZN9A0GM

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 adapalene and benzoyl peroxide (source: ndc)

Generic Name adapalene and benzoyl peroxide (source: ndc)

Application Number ANDA214553 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

3 mg/g
25 mg/g

source: ndc

Packaging

1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-02) / 60 g in 1 BOTTLE, PUMP
1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-04) / 45 g in 1 BOTTLE, PUMP

source: ndc

Packages (2)

72578-119-02 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-02) / 60 g in 1 BOTTLE, PUMP 72578-119-04 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-04) / 45 g in 1 BOTTLE, PUMP

Ingredients (2)

adapalene (3 mg/g) benzoyl peroxide (25 mg/g)

Linked Drug Pages (1)

Adapalene and benzoyl peroxide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "edefb257-b872-45cb-a882-fa6991d6cb57", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["1663745"], "spl_set_id": ["3a0fa489-4720-4760-a476-2317aef5a231"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-02)  / 60 g in 1 BOTTLE, PUMP", "package_ndc": "72578-119-02", "marketing_start_date": "20220606"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-04)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "72578-119-04", "marketing_start_date": "20220606"}], "brand_name": "Adapalene and benzoyl peroxide", "product_id": "72578-119_edefb257-b872-45cb-a882-fa6991d6cb57", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "72578-119", "generic_name": "Adapalene and benzoyl peroxide", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adapalene and benzoyl peroxide", "active_ingredients": [{"name": "ADAPALENE", "strength": "3 mg/g"}, {"name": "BENZOYL PEROXIDE", "strength": "25 mg/g"}], "application_number": "ANDA214553", "marketing_category": "ANDA", "marketing_start_date": "20220606", "listing_expiration_date": "20261231"}