finacea foam

Generic: azelaic acid

Labeler: leo pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name finacea foam
Generic Name azelaic acid
Labeler leo pharma inc.
Dosage Form AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

azelaic acid .15 g/g

Manufacturer
LEO Pharma Inc.

Identifiers & Regulatory

Product NDC 50222-303
Product ID 50222-303_f51a0452-513f-488f-b0f9-b723cf96bdf7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207071
Listing Expiration 2026-12-31
Marketing Start 2018-10-01

Pharmacologic Class

Physiologic Effect
decreased protein synthesis [pe] decreased sebaceous gland activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50222303
Hyphenated Format 50222-303

Supplemental Identifiers

RxCUI
1659800 1659803
UNII
F2VW3D43YT
NUI
N0000008841 N0000009982

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 finacea foam (source: ndc)
Generic Name azelaic acid (source: ndc)
Application Number NDA207071 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .15 g/g
source: ndc
Packaging
  • 1 CAN in 1 CARTON (50222-303-50) / 50 g in 1 CAN
  • 1 CAN in 1 CARTON (50222-303-91) / 15 g in 1 CAN
source: ndc

Packages (2)

50222-303-50 1 CAN in 1 CARTON (50222-303-50) / 50 g in 1 CAN 50222-303-91 1 CAN in 1 CARTON (50222-303-91) / 15 g in 1 CAN

Ingredients (1)

azelaic acid (.15 g/g)

Linked Drug Pages (1)

FINACEA FOAM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "f51a0452-513f-488f-b0f9-b723cf96bdf7", "openfda": {"nui": ["N0000008841", "N0000009982"], "unii": ["F2VW3D43YT"], "rxcui": ["1659800", "1659803"], "spl_set_id": ["9fabd24e-4c3b-49a0-aa5f-c8d75ae67572"], "pharm_class_pe": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "manufacturer_name": ["LEO Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CAN in 1 CARTON (50222-303-50)  / 50 g in 1 CAN", "package_ndc": "50222-303-50", "marketing_start_date": "20181001"}, {"sample": true, "description": "1 CAN in 1 CARTON (50222-303-91)  / 15 g in 1 CAN", "package_ndc": "50222-303-91", "marketing_start_date": "20181001"}], "brand_name": "FINACEA FOAM", "product_id": "50222-303_f51a0452-513f-488f-b0f9-b723cf96bdf7", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "product_ndc": "50222-303", "generic_name": "azelaic acid", "labeler_name": "LEO Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FINACEA FOAM", "active_ingredients": [{"name": "AZELAIC ACID", "strength": ".15 g/g"}], "application_number": "NDA207071", "marketing_category": "NDA", "marketing_start_date": "20181001", "listing_expiration_date": "20261231"}