azelaic acid

Generic: azelaic acid

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelaic acid
Generic Name azelaic acid
Labeler glenmark pharmaceuticals inc., usa
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

azelaic acid .15 g/g

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-626
Product ID 68462-626_28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204637
Listing Expiration 2026-12-31
Marketing Start 2018-11-19

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 68462626
Hyphenated Format 68462-626

Supplemental Identifiers

RxCUI
1041518
UPC
0368462626528
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 (source: ndc)
Generic Name azelaic acid (source: ndc)
Application Number ANDA204637 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .15 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68462-626-52) / 50 g in 1 TUBE
source: ndc

Packages (1)

68462-626-52 1 TUBE in 1 CARTON (68462-626-52) / 50 g in 1 TUBE

Ingredients (1)

azelaic acid (.15 g/g)

Linked Drug Pages (1)

azelaic acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6", "openfda": {"nui": ["N0000008841", "N0000009982"], "upc": ["0368462626528"], "unii": ["F2VW3D43YT"], "rxcui": ["1041518"], "spl_set_id": ["0b5ab22e-c78a-4429-9a76-a4ba2d11fcde"], "pharm_class_pe": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68462-626-52)  / 50 g in 1 TUBE", "package_ndc": "68462-626-52", "marketing_start_date": "20181119"}], "brand_name": "azelaic acid", "product_id": "68462-626_28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6", "dosage_form": "GEL", "pharm_class": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "product_ndc": "68462-626", "generic_name": "azelaic acid", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azelaic acid", "active_ingredients": [{"name": "AZELAIC ACID", "strength": ".15 g/g"}], "application_number": "ANDA204637", "marketing_category": "ANDA", "marketing_start_date": "20181119", "listing_expiration_date": "20261231"}