azelaic acid gel

Generic: azelaic acid

Labeler: sandoz inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name azelaic acid gel
Generic Name azelaic acid
Labeler sandoz inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

azelaic acid .15 g/g

Manufacturer
Sandoz Inc.

Identifiers & Regulatory

Product NDC 0781-7172
Product ID 0781-7172_d6c8343f-d169-4924-9fa2-4fbf097a32a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021470
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 07817172
Hyphenated Format 0781-7172

Supplemental Identifiers

RxCUI
1041518
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 azelaic acid gel (source: ndc)
Generic Name azelaic acid (source: ndc)
Application Number NDA021470 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .15 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0781-7172-50) / 50 g in 1 TUBE
source: ndc

Packages (1)

0781-7172-50 1 TUBE in 1 CARTON (0781-7172-50) / 50 g in 1 TUBE

Ingredients (1)

azelaic acid (.15 g/g)

Linked Drug Pages (1)

Azelaic Acid Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d6c8343f-d169-4924-9fa2-4fbf097a32a7", "openfda": {"nui": ["N0000008841", "N0000009982"], "unii": ["F2VW3D43YT"], "rxcui": ["1041518"], "spl_set_id": ["66178511-5c1a-4ecd-bc98-2ceb54e710ac"], "pharm_class_pe": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "manufacturer_name": ["Sandoz Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0781-7172-50)  / 50 g in 1 TUBE", "package_ndc": "0781-7172-50", "marketing_start_date": "20181001"}], "brand_name": "Azelaic Acid Gel", "product_id": "0781-7172_d6c8343f-d169-4924-9fa2-4fbf097a32a7", "dosage_form": "GEL", "pharm_class": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "product_ndc": "0781-7172", "generic_name": "azelaic acid", "labeler_name": "Sandoz Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelaic Acid Gel", "active_ingredients": [{"name": "AZELAIC ACID", "strength": ".15 g/g"}], "application_number": "NDA021470", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20181001", "listing_expiration_date": "20261231"}