adapalene and benzoyl peroxide

Generic: adapalene and benzoyl peroxide topical

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene and benzoyl peroxide
Generic Name adapalene and benzoyl peroxide topical
Labeler alembic pharmaceuticals limited
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-662
Product ID 46708-662_528fc681-2ba1-442f-812f-339f90b0a030
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214185
Listing Expiration 2026-12-31
Marketing Start 2025-05-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708662
Hyphenated Format 46708-662

Supplemental Identifiers

RxCUI
1663745
UPC
0362332662456
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 topical (source: ndc)
Application Number ANDA214185 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
  • 25 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (46708-662-45) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

46708-662-45 1 BOTTLE, PUMP in 1 CARTON (46708-662-45) / 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": "528fc681-2ba1-442f-812f-339f90b0a030", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0362332662456"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["1663745"], "spl_set_id": ["2d4e5111-4f9f-42dd-8cf7-56bdc51fbbad"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (46708-662-45)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "46708-662-45", "marketing_start_date": "20250521"}], "brand_name": "ADAPALENE AND BENZOYL PEROXIDE", "product_id": "46708-662_528fc681-2ba1-442f-812f-339f90b0a030", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "46708-662", "generic_name": "adapalene and benzoyl peroxide topical", "labeler_name": "Alembic Pharmaceuticals Limited", "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": "ANDA214185", "marketing_category": "ANDA", "marketing_start_date": "20250521", "listing_expiration_date": "20261231"}