azelex

Generic: azelaic acid

Labeler: almirall, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelex
Generic Name azelaic acid
Labeler almirall, llc
Dosage Form CREAM
Routes
CUTANEOUS
Active Ingredients

azelaic acid .2 g/g

Manufacturer
Almirall, LLC

Identifiers & Regulatory

Product NDC 16110-869
Product ID 16110-869_ae821f0c-ec53-4612-a505-e1aa9d73a158
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020428
Listing Expiration 2026-12-31
Marketing Start 2018-09-24

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 16110869
Hyphenated Format 16110-869

Supplemental Identifiers

RxCUI
1041520 1043753
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 azelex (source: ndc)
Generic Name azelaic acid (source: ndc)
Application Number NDA020428 (source: ndc)
Routes
CUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .2 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (16110-869-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (16110-869-50) / 50 g in 1 TUBE
source: ndc

Packages (2)

16110-869-30 1 TUBE in 1 CARTON (16110-869-30) / 30 g in 1 TUBE 16110-869-50 1 TUBE in 1 CARTON (16110-869-50) / 50 g in 1 TUBE

Ingredients (1)

azelaic acid (.2 g/g)

Linked Drug Pages (1)

AZELEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["CUTANEOUS"], "spl_id": "ae821f0c-ec53-4612-a505-e1aa9d73a158", "openfda": {"nui": ["N0000008841", "N0000009982"], "unii": ["F2VW3D43YT"], "rxcui": ["1041520", "1043753"], "spl_set_id": ["ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75"], "pharm_class_pe": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "manufacturer_name": ["Almirall, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (16110-869-30)  / 30 g in 1 TUBE", "package_ndc": "16110-869-30", "marketing_start_date": "20190712"}, {"sample": false, "description": "1 TUBE in 1 CARTON (16110-869-50)  / 50 g in 1 TUBE", "package_ndc": "16110-869-50", "marketing_start_date": "20190712"}], "brand_name": "AZELEX", "product_id": "16110-869_ae821f0c-ec53-4612-a505-e1aa9d73a158", "dosage_form": "CREAM", "pharm_class": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "product_ndc": "16110-869", "generic_name": "azelaic acid", "labeler_name": "Almirall, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZELEX", "active_ingredients": [{"name": "AZELAIC ACID", "strength": ".2 g/g"}], "application_number": "NDA020428", "marketing_category": "NDA", "marketing_start_date": "20180924", "listing_expiration_date": "20261231"}