adapalene

Generic: adapalene

Labeler: e. fougera & co. a division of fougera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene
Generic Name adapalene
Labeler e. fougera & co. a division of fougera pharmaceuticals, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

adapalene 1 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0424
Product ID 0168-0424_3704e230-6ad8-448d-a4bf-a86c449837b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090824
Listing Expiration 2027-12-31
Marketing Start 2010-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680424
Hyphenated Format 0168-0424

Supplemental Identifiers

RxCUI
313852
UPC
0301680424460
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 ANDA090824 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0168-0424-46) / 45 g in 1 TUBE
source: ndc

Packages (1)

0168-0424-46 1 TUBE in 1 CARTON (0168-0424-46) / 45 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": "3704e230-6ad8-448d-a4bf-a86c449837b9", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0301680424460"], "unii": ["1L4806J2QF"], "rxcui": ["313852"], "spl_set_id": ["276f7cce-5f54-40f8-8321-9192d0e52a73"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0168-0424-46)  / 45 g in 1 TUBE", "package_ndc": "0168-0424-46", "marketing_start_date": "20100630"}], "brand_name": "Adapalene", "product_id": "0168-0424_3704e230-6ad8-448d-a4bf-a86c449837b9", "dosage_form": "CREAM", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0168-0424", "generic_name": "adapalene", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adapalene", "active_ingredients": [{"name": "ADAPALENE", "strength": "1 mg/g"}], "application_number": "ANDA090824", "marketing_category": "ANDA", "marketing_start_date": "20100630", "listing_expiration_date": "20271231"}