azelaic acid

Generic: azelaic acid

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelaic acid
Generic Name azelaic acid
Labeler actavis pharma, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

azelaic acid .15 g/g

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2131
Product ID 0591-2131_38d8c966-bb27-4b39-b436-4e7ffbd2d134
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208011
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 05912131
Hyphenated Format 0591-2131

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 ANDA208011 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .15 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0591-2131-55) / 50 g in 1 TUBE
source: ndc

Packages (1)

0591-2131-55 1 TUBE in 1 CARTON (0591-2131-55) / 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": "38d8c966-bb27-4b39-b436-4e7ffbd2d134", "openfda": {"nui": ["N0000008841", "N0000009982"], "unii": ["F2VW3D43YT"], "rxcui": ["1041518"], "spl_set_id": ["66298d50-d4e2-4852-bbab-581389c488cb"], "pharm_class_pe": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0591-2131-55)  / 50 g in 1 TUBE", "package_ndc": "0591-2131-55", "marketing_start_date": "20181119"}], "brand_name": "azelaic acid", "product_id": "0591-2131_38d8c966-bb27-4b39-b436-4e7ffbd2d134", "dosage_form": "GEL", "pharm_class": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "product_ndc": "0591-2131", "generic_name": "azelaic acid", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azelaic acid", "active_ingredients": [{"name": "AZELAIC ACID", "strength": ".15 g/g"}], "application_number": "ANDA208011", "marketing_category": "ANDA", "marketing_start_date": "20181119", "listing_expiration_date": "20261231"}