adapalene

Generic: adapalene

Labeler: topco associates
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene
Generic Name adapalene
Labeler topco associates
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 1 mg/g

Manufacturer
Topco Associates

Identifiers & Regulatory

Product NDC 76162-114
Product ID 76162-114_144e4db6-6253-4c98-b571-ea1108c177d6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090962
Listing Expiration 2026-12-31
Marketing Start 2023-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162114
Hyphenated Format 76162-114

Supplemental Identifiers

RxCUI
307731
UPC
0036800469778
UNII
1L4806J2QF
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 (source: ndc)
Generic Name adapalene (source: ndc)
Application Number ANDA090962 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (76162-114-05) / 15 g in 1 TUBE
source: ndc

Packages (1)

76162-114-05 1 TUBE in 1 CARTON (76162-114-05) / 15 g in 1 TUBE

Ingredients (1)

adapalene (1 mg/g)

Linked Drug Pages (1)

Adapalene ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "144e4db6-6253-4c98-b571-ea1108c177d6", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0036800469778"], "unii": ["1L4806J2QF"], "rxcui": ["307731"], "spl_set_id": ["5693e3c9-00e5-4e62-b44a-47be2dc31811"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Topco Associates"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (76162-114-05)  / 15 g in 1 TUBE", "package_ndc": "76162-114-05", "marketing_start_date": "20231130"}], "brand_name": "Adapalene", "product_id": "76162-114_144e4db6-6253-4c98-b571-ea1108c177d6", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "76162-114", "generic_name": "Adapalene", "labeler_name": "Topco Associates", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Adapalene", "active_ingredients": [{"name": "ADAPALENE", "strength": "1 mg/g"}], "application_number": "ANDA090962", "marketing_category": "ANDA", "marketing_start_date": "20231130", "listing_expiration_date": "20261231"}