adapalene and benzoyl peroxide

Generic: adapalene and benzoyl peroxide

Labeler: zydus lifesciences 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
Labeler zydus lifesciences limited
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1716
Product ID 70771-1716_2825a88e-4c88-4703-9128-ad478f3aae28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214553
Listing Expiration 2026-12-31
Marketing Start 2022-06-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711716
Hyphenated Format 70771-1716

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 ANDA214553 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
  • 25 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-3) / 60 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-4) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

70771-1716-3 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-3) / 60 g in 1 BOTTLE, PUMP 70771-1716-4 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-4) / 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": "2825a88e-4c88-4703-9128-ad478f3aae28", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["1663745"], "spl_set_id": ["d374a9b9-3ee9-4bc4-bcb9-a947d76cb6e5"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-3)  / 60 g in 1 BOTTLE, PUMP", "package_ndc": "70771-1716-3", "marketing_start_date": "20220606"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-4)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "70771-1716-4", "marketing_start_date": "20220606"}], "brand_name": "Adapalene and benzoyl peroxide", "product_id": "70771-1716_2825a88e-4c88-4703-9128-ad478f3aae28", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "70771-1716", "generic_name": "Adapalene and benzoyl peroxide", "labeler_name": "Zydus Lifesciences 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": "ANDA214553", "marketing_category": "ANDA", "marketing_start_date": "20220606", "listing_expiration_date": "20261231"}