adapalene and benzoyl peroxide (68462-301)

Drug Facts

Product Profile

Brand Name adapalene and benzoyl peroxide

Generic Name adapalene and benzoyl peroxide

Labeler glenmark pharmaceuticals inc., usa

Dosage Form GEL

Routes

TOPICAL

Active Ingredients

adapalene 1 mg/g, benzoyl peroxide 25 mg/g

Manufacturer

Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-301

Product ID 68462-301_194a1ade-7163-4a56-ad50-6220398ede14

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208108

Listing Expiration 2027-12-31

Marketing Start 2019-11-08

Pharmacologic Class

Established (EPC)

retinoid [epc]

Chemical Structure

retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462301

Hyphenated Format 68462-301

Supplemental Identifiers

RxCUI

829539

UPC

0368462301470

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 ANDA208108 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

1 mg/g
25 mg/g

source: ndc

Packaging

1 BOTTLE, PUMP in 1 CARTON (68462-301-47) / 45 g in 1 BOTTLE, PUMP
45 g in 1 TUBE (68462-301-55)

source: ndc

Packages (2)

68462-301-47 1 BOTTLE, PUMP in 1 CARTON (68462-301-47) / 45 g in 1 BOTTLE, PUMP 68462-301-55 45 g in 1 TUBE (68462-301-55)

Ingredients (2)

adapalene (1 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": "194a1ade-7163-4a56-ad50-6220398ede14", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0368462301470"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["829539"], "spl_set_id": ["fc8e868f-9699-4ae6-83d5-fa27789336cd"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68462-301-47)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "68462-301-47", "marketing_start_date": "20191108"}, {"sample": false, "description": "45 g in 1 TUBE (68462-301-55)", "package_ndc": "68462-301-55", "marketing_start_date": "20191108"}], "brand_name": "adapalene and benzoyl peroxide", "product_id": "68462-301_194a1ade-7163-4a56-ad50-6220398ede14", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "68462-301", "generic_name": "adapalene and benzoyl peroxide", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "adapalene and benzoyl peroxide", "active_ingredients": [{"name": "ADAPALENE", "strength": "1 mg/g"}, {"name": "BENZOYL PEROXIDE", "strength": "25 mg/g"}], "application_number": "ANDA208108", "marketing_category": "ANDA", "marketing_start_date": "20191108", "listing_expiration_date": "20271231"}