azelaic acid

Generic: azelaic acid

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelaic acid
Generic Name azelaic acid
Labeler sun pharmaceutical industries, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

azelaic acid .15 g/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1389
Product ID 51672-1389_3cf92843-22fd-ba71-e063-6294a90a1fc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210549
Listing Expiration 2026-12-31
Marketing Start 2019-08-23

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 516721389
Hyphenated Format 51672-1389

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 (source: ndc)
Generic Name azelaic acid (source: ndc)
Application Number ANDA210549 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .15 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-1389-3) / 50 g in 1 TUBE
source: ndc

Packages (1)

51672-1389-3 1 TUBE in 1 CARTON (51672-1389-3) / 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": "3cf92843-22fd-ba71-e063-6294a90a1fc6", "openfda": {"nui": ["N0000008841", "N0000009982"], "unii": ["F2VW3D43YT"], "rxcui": ["1041518"], "spl_set_id": ["d4e9e95d-1ebd-44df-a91e-59819715659c"], "pharm_class_pe": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-1389-3)  / 50 g in 1 TUBE", "package_ndc": "51672-1389-3", "marketing_start_date": "20190823"}], "brand_name": "Azelaic Acid", "product_id": "51672-1389_3cf92843-22fd-ba71-e063-6294a90a1fc6", "dosage_form": "GEL", "pharm_class": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "product_ndc": "51672-1389", "generic_name": "Azelaic Acid", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelaic Acid", "active_ingredients": [{"name": "AZELAIC ACID", "strength": ".15 g/g"}], "application_number": "ANDA210549", "marketing_category": "ANDA", "marketing_start_date": "20190823", "listing_expiration_date": "20261231"}