adapalene

Generic: adapalene

Labeler: top care (topco associates llc)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene
Generic Name adapalene
Labeler top care (topco associates llc)
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 1 mg/g

Manufacturer
TOP CARE (Topco Associates LLC)

Identifiers & Regulatory

Product NDC 36800-088
Product ID 36800-088_eaf6cd8c-63b5-42e9-aeaa-e911c19b9e4c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091314
Listing Expiration 2026-12-31
Marketing Start 2020-07-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800088
Hyphenated Format 36800-088

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 ANDA091314 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (36800-088-05) / 15 g in 1 TUBE
source: ndc

Packages (1)

36800-088-05 1 TUBE in 1 CARTON (36800-088-05) / 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": "eaf6cd8c-63b5-42e9-aeaa-e911c19b9e4c", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0036800469778"], "unii": ["1L4806J2QF"], "rxcui": ["307731"], "spl_set_id": ["07351ab9-ed46-4ef8-85f3-bb6cc7af17c3"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["TOP CARE (Topco Associates LLC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (36800-088-05)  / 15 g in 1 TUBE", "package_ndc": "36800-088-05", "marketing_start_date": "20200730"}], "brand_name": "Adapalene", "product_id": "36800-088_eaf6cd8c-63b5-42e9-aeaa-e911c19b9e4c", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "36800-088", "generic_name": "Adapalene", "labeler_name": "TOP CARE (Topco Associates LLC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Adapalene", "active_ingredients": [{"name": "ADAPALENE", "strength": "1 mg/g"}], "application_number": "ANDA091314", "marketing_category": "ANDA", "marketing_start_date": "20200730", "listing_expiration_date": "20261231"}