adapalene and benzoyl peroxide (45802-846)

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 .1 g/100g, benzoyl peroxide 2.5 g/100g

Manufacturer

Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-846

Product ID 45802-846_23db18aa-6627-4833-bc30-575a796473dc

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205033

Listing Expiration 2026-12-31

Marketing Start 2018-01-24

Pharmacologic Class

Established (EPC)

retinoid [epc]

Chemical Structure

retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802846

Hyphenated Format 45802-846

Supplemental Identifiers

RxCUI

829539

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 ANDA205033 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

.1 g/100g
2.5 g/100g

source: ndc

Packaging

45 g in 1 BOTTLE, PUMP (45802-846-01)

source: ndc

Packages (1)

45802-846-01 45 g in 1 BOTTLE, PUMP (45802-846-01)

Ingredients (2)

adapalene (.1 g/100g) benzoyl peroxide (2.5 g/100g)

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": "23db18aa-6627-4833-bc30-575a796473dc", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["829539"], "spl_set_id": ["e50e3ef9-3a9b-4172-a908-71c973a7fb5c"], "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 (45802-846-01)", "package_ndc": "45802-846-01", "marketing_start_date": "20180124"}], "brand_name": "adapalene and benzoyl peroxide", "product_id": "45802-846_23db18aa-6627-4833-bc30-575a796473dc", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "45802-846", "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": ".1 g/100g"}, {"name": "BENZOYL PEROXIDE", "strength": "2.5 g/100g"}], "application_number": "ANDA205033", "marketing_category": "ANDA", "marketing_start_date": "20180124", "listing_expiration_date": "20261231"}