dapsone

Generic: dapsone

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dapsone 100 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1477
Product ID 67046-1477_2d018cbb-21a4-5f63-e063-6394a90aadc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207165
Listing Expiration 2026-12-31
Marketing Start 2025-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461477
Hyphenated Format 67046-1477

Supplemental Identifiers

RxCUI
197557
UNII
8W5C518302
NUI
N0000175881 M0020791

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 dapsone (source: ndc)
Generic Name dapsone (source: ndc)
Application Number ANDA207165 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1477-3)
source: ndc

Packages (1)

67046-1477-3 30 TABLET in 1 BLISTER PACK (67046-1477-3)

Ingredients (1)

dapsone (100 mg/1)

Linked Drug Pages (1)

Dapsone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d018cbb-21a4-5f63-e063-6394a90aadc3", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["197557"], "spl_set_id": ["2d018cbb-21b2-5f63-e063-6394a90aadc3"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1477-3)", "package_ndc": "67046-1477-3", "marketing_start_date": "20250131"}], "brand_name": "Dapsone", "product_id": "67046-1477_2d018cbb-21a4-5f63-e063-6394a90aadc3", "dosage_form": "TABLET", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "67046-1477", "generic_name": "dapsone", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "100 mg/1"}], "application_number": "ANDA207165", "marketing_category": "ANDA", "marketing_start_date": "20250131", "listing_expiration_date": "20261231"}