adapalene

Generic: adapalene

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene
Generic Name adapalene
Labeler actavis pharma, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 3 mg/g

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0472-0126
Product ID 0472-0126_9bada4fd-f276-4355-bed1-ae5eee087c95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201000
Listing Expiration 2026-12-31
Marketing Start 2014-10-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04720126
Hyphenated Format 0472-0126

Supplemental Identifiers

RxCUI
722111
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 ANDA201000 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0472-0126-45) / 45 g in 1 TUBE
source: ndc

Packages (1)

0472-0126-45 1 TUBE in 1 CARTON (0472-0126-45) / 45 g in 1 TUBE

Ingredients (1)

adapalene (3 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": "9bada4fd-f276-4355-bed1-ae5eee087c95", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF"], "rxcui": ["722111"], "spl_set_id": ["aacd5ec4-e2fa-460e-aaae-a0aba5c052e5"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0472-0126-45)  / 45 g in 1 TUBE", "package_ndc": "0472-0126-45", "marketing_start_date": "20141027"}], "brand_name": "adapalene", "product_id": "0472-0126_9bada4fd-f276-4355-bed1-ae5eee087c95", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0472-0126", "generic_name": "adapalene", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "adapalene", "active_ingredients": [{"name": "ADAPALENE", "strength": "3 mg/g"}], "application_number": "ANDA201000", "marketing_category": "ANDA", "marketing_start_date": "20141027", "listing_expiration_date": "20261231"}