aczone

Generic: dapsone

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aczone
Generic Name dapsone
Labeler allergan, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

dapsone 50 mg/g

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0023-3670
Product ID 0023-3670_8d6a6d88-5639-4b7b-a712-d0600de69b02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021794
Listing Expiration 2026-12-31
Marketing Start 2009-06-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00233670
Hyphenated Format 0023-3670

Supplemental Identifiers

RxCUI
607295 701858
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 NDA021794 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 15 TUBE in 1 CARTON (0023-3670-03) / 3 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0023-3670-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0023-3670-60) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0023-3670-90) / 90 g in 1 TUBE
source: ndc

Packages (4)

0023-3670-03 15 TUBE in 1 CARTON (0023-3670-03) / 3 g in 1 TUBE 0023-3670-30 1 TUBE in 1 CARTON (0023-3670-30) / 30 g in 1 TUBE 0023-3670-60 1 TUBE in 1 CARTON (0023-3670-60) / 60 g in 1 TUBE 0023-3670-90 1 TUBE in 1 CARTON (0023-3670-90) / 90 g in 1 TUBE

Ingredients (1)

dapsone (50 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": "8d6a6d88-5639-4b7b-a712-d0600de69b02", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["607295", "701858"], "spl_set_id": ["b7d605cf-bf84-461b-939b-1f773a4cba65"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 TUBE in 1 CARTON (0023-3670-03)  / 3 g in 1 TUBE", "package_ndc": "0023-3670-03", "marketing_start_date": "20090624"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0023-3670-30)  / 30 g in 1 TUBE", "package_ndc": "0023-3670-30", "marketing_start_date": "20090624"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0023-3670-60)  / 60 g in 1 TUBE", "package_ndc": "0023-3670-60", "marketing_start_date": "20090624"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0023-3670-90)  / 90 g in 1 TUBE", "package_ndc": "0023-3670-90", "marketing_start_date": "20090624"}], "brand_name": "ACZONE", "product_id": "0023-3670_8d6a6d88-5639-4b7b-a712-d0600de69b02", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "0023-3670", "generic_name": "dapsone", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACZONE", "active_ingredients": [{"name": "DAPSONE", "strength": "50 mg/g"}], "application_number": "NDA021794", "marketing_category": "NDA", "marketing_start_date": "20090624", "listing_expiration_date": "20261231"}