azelaic acid gel

Generic: azelaic acid

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

azelaic acid .15 g/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-038
Product ID 21922-038_433f2929-0ee4-4b1f-a548-eff7b66e7fb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208724
Listing Expiration 2026-12-31
Marketing Start 2023-11-30

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 21922038
Hyphenated Format 21922-038

Supplemental Identifiers

RxCUI
1041518
UPC
0321922038149
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 ANDA208724 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .15 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-038-14) / 50 g in 1 TUBE
source: ndc

Packages (1)

21922-038-14 1 TUBE in 1 CARTON (21922-038-14) / 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": "433f2929-0ee4-4b1f-a548-eff7b66e7fb6", "openfda": {"nui": ["N0000008841", "N0000009982"], "upc": ["0321922038149"], "unii": ["F2VW3D43YT"], "rxcui": ["1041518"], "spl_set_id": ["ab3f174c-a3c4-4ae9-b0bc-954efaadf8de"], "pharm_class_pe": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-038-14)  / 50 g in 1 TUBE", "package_ndc": "21922-038-14", "marketing_start_date": "20231130"}], "brand_name": "Azelaic Acid Gel", "product_id": "21922-038_433f2929-0ee4-4b1f-a548-eff7b66e7fb6", "dosage_form": "GEL", "pharm_class": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "product_ndc": "21922-038", "generic_name": "Azelaic Acid", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelaic Acid Gel", "active_ingredients": [{"name": "AZELAIC ACID", "strength": ".15 g/g"}], "application_number": "ANDA208724", "marketing_category": "ANDA", "marketing_start_date": "20231130", "listing_expiration_date": "20261231"}