adapalene and benzoyl peroxide

Generic: adapalene and benzoyl peroxide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene and benzoyl peroxide
Generic Name adapalene and benzoyl peroxide
Labeler sun pharmaceutical industries, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1384
Product ID 51672-1384_38efdb2e-a94e-0df0-e063-6394a90a98e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209148
Listing Expiration 2026-12-31
Marketing Start 2018-10-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721384
Hyphenated Format 51672-1384

Supplemental Identifiers

RxCUI
1663745
UPC
0351672138493
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 ANDA209148 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
  • 25 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (51672-1384-4) / 60 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (51672-1384-9) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

51672-1384-4 1 BOTTLE, PUMP in 1 CARTON (51672-1384-4) / 60 g in 1 BOTTLE, PUMP 51672-1384-9 1 BOTTLE, PUMP in 1 CARTON (51672-1384-9) / 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": "38efdb2e-a94e-0df0-e063-6394a90a98e9", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0351672138493"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["1663745"], "spl_set_id": ["13fc72e9-7178-4a8b-9fe8-d88ba591dac8"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (51672-1384-4)  / 60 g in 1 BOTTLE, PUMP", "package_ndc": "51672-1384-4", "marketing_start_date": "20210311"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (51672-1384-9)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "51672-1384-9", "marketing_start_date": "20181017"}], "brand_name": "Adapalene and Benzoyl Peroxide", "product_id": "51672-1384_38efdb2e-a94e-0df0-e063-6394a90a98e9", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "51672-1384", "generic_name": "ADAPALENE and BENZOYL PEROXIDE", "labeler_name": "Sun Pharmaceutical Industries, 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": "ANDA209148", "marketing_category": "ANDA", "marketing_start_date": "20181017", "listing_expiration_date": "20261231"}