adapalene

Generic: adaplane 0.1%

Labeler: acne free, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene
Generic Name adaplane 0.1%
Labeler acne free, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene .1 g/g

Manufacturer
Acne Free, LLC

Identifiers & Regulatory

Product NDC 80861-115
Product ID 80861-115_3aaef113-7ec1-ba6b-e063-6394a90a67e9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091314
Listing Expiration 2026-12-31
Marketing Start 2024-01-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80861115
Hyphenated Format 80861-115

Supplemental Identifiers

UPC
0850039795091
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 adaplane 0.1% (source: ndc)
Application Number ANDA091314 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 g/g
source: ndc
Packaging
  • 1 g in 1 TUBE (80861-115-01)
source: ndc

Packages (1)

80861-115-01 1 g in 1 TUBE (80861-115-01)

Ingredients (1)

adapalene (.1 g/g)

Linked Drug Pages (1)

Adapalene ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3aaef113-7ec1-ba6b-e063-6394a90a67e9", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0850039795091"], "unii": ["1L4806J2QF"], "spl_set_id": ["0dc574e0-397a-7bc8-e063-6394a90a27e2"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Acne Free, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 g in 1 TUBE (80861-115-01)", "package_ndc": "80861-115-01", "marketing_start_date": "20240105"}], "brand_name": "Adapalene", "product_id": "80861-115_3aaef113-7ec1-ba6b-e063-6394a90a67e9", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "80861-115", "generic_name": "Adaplane 0.1%", "labeler_name": "Acne Free, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Adapalene", "active_ingredients": [{"name": "ADAPALENE", "strength": ".1 g/g"}], "application_number": "ANDA091314", "marketing_category": "ANDA", "marketing_start_date": "20240105", "listing_expiration_date": "20261231"}