aczone

Generic: dapsone

Labeler: almirall, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aczone
Generic Name dapsone
Labeler almirall, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

dapsone 75 mg/g

Manufacturer
Almirall, LLC

Identifiers & Regulatory

Product NDC 16110-526
Product ID 16110-526_fee319ef-b2af-415e-8e91-32aaccc024da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207154
Listing Expiration 2026-12-31
Marketing Start 2019-09-10

Pharmacologic Class

Established (EPC)
sulfone [epc]
Chemical Structure
sulfones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16110526
Hyphenated Format 16110-526

Supplemental Identifiers

RxCUI
1741905 1741907
UNII
8W5C518302
NUI
N0000175881 M0020791

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 aczone (source: ndc)
Generic Name dapsone (source: ndc)
Application Number NDA207154 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (16110-526-60) / 60 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (16110-526-90) / 90 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

16110-526-60 1 BOTTLE, PUMP in 1 CARTON (16110-526-60) / 60 g in 1 BOTTLE, PUMP 16110-526-90 1 BOTTLE, PUMP in 1 CARTON (16110-526-90) / 90 g in 1 BOTTLE, PUMP

Ingredients (1)

dapsone (75 mg/g)

Linked Drug Pages (1)

Aczone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "fee319ef-b2af-415e-8e91-32aaccc024da", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["1741905", "1741907"], "spl_set_id": ["22058b7d-a578-4eaa-a476-ac982337f02a"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Almirall, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (16110-526-60)  / 60 g in 1 BOTTLE, PUMP", "package_ndc": "16110-526-60", "marketing_start_date": "20190910"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (16110-526-90)  / 90 g in 1 BOTTLE, PUMP", "package_ndc": "16110-526-90", "marketing_start_date": "20190910"}], "brand_name": "Aczone", "product_id": "16110-526_fee319ef-b2af-415e-8e91-32aaccc024da", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "16110-526", "generic_name": "dapsone", "labeler_name": "Almirall, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aczone", "active_ingredients": [{"name": "DAPSONE", "strength": "75 mg/g"}], "application_number": "NDA207154", "marketing_category": "NDA", "marketing_start_date": "20190910", "listing_expiration_date": "20261231"}