adapalene and benzoyl peroxide (45802-853)

Drug Facts

Product Profile

Brand Name adapalene and benzoyl peroxide

Generic Name adapalene and benzoyl peroxide

Labeler padagis israel pharmaceuticals ltd

Dosage Form GEL

Routes

TOPICAL

Active Ingredients

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

Manufacturer

Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-853

Product ID 45802-853_92dcba02-f42f-482d-8cd5-2b5ab8fa540a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212464

Listing Expiration 2026-12-31

Marketing Start 2022-06-02

Pharmacologic Class

Established (EPC)

retinoid [epc]

Chemical Structure

retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802853

Hyphenated Format 45802-853

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 ANDA212464 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

3 mg/g
25 mg/g

source: ndc

Packaging

45 g in 1 BOTTLE, PUMP (45802-853-45)

source: ndc

Packages (1)

45802-853-45 45 g in 1 BOTTLE, PUMP (45802-853-45)

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": "92dcba02-f42f-482d-8cd5-2b5ab8fa540a", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["1663745"], "spl_set_id": ["92dcba02-f42f-482d-8cd5-2b5ab8fa540a"], "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": "45 g in 1 BOTTLE, PUMP (45802-853-45)", "package_ndc": "45802-853-45", "marketing_start_date": "20220602"}], "brand_name": "ADAPALENE AND BENZOYL PEROXIDE", "product_id": "45802-853_92dcba02-f42f-482d-8cd5-2b5ab8fa540a", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "45802-853", "generic_name": "adapalene and benzoyl peroxide", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "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": "ANDA212464", "marketing_category": "ANDA", "marketing_start_date": "20220602", "listing_expiration_date": "20261231"}