dapsone

Generic: dapsone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dapsone 25 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-988
Product ID 82804-988_9cfe5fe7-abc7-4f48-a597-1b1a5c70a354
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086841
Listing Expiration 2026-12-31
Marketing Start 2024-01-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804988
Hyphenated Format 82804-988

Supplemental Identifiers

RxCUI
197557 197558
UPC
0382804989300 0382804988303
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 ANDA086841 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (82804-988-00)
  • 1000 TABLET in 1 BOTTLE (82804-988-11)
  • 30 TABLET in 1 BOTTLE (82804-988-30)
  • 500 TABLET in 1 BOTTLE (82804-988-55)
  • 60 TABLET in 1 BOTTLE (82804-988-60)
  • 240 TABLET in 1 BOTTLE (82804-988-64)
  • 120 TABLET in 1 BOTTLE (82804-988-72)
  • 180 TABLET in 1 BOTTLE (82804-988-78)
  • 90 TABLET in 1 BOTTLE (82804-988-90)
source: ndc

Packages (9)

82804-988-00 100 TABLET in 1 BOTTLE (82804-988-00) 82804-988-11 1000 TABLET in 1 BOTTLE (82804-988-11) 82804-988-30 30 TABLET in 1 BOTTLE (82804-988-30) 82804-988-55 500 TABLET in 1 BOTTLE (82804-988-55) 82804-988-60 60 TABLET in 1 BOTTLE (82804-988-60) 82804-988-64 240 TABLET in 1 BOTTLE (82804-988-64) 82804-988-72 120 TABLET in 1 BOTTLE (82804-988-72) 82804-988-78 180 TABLET in 1 BOTTLE (82804-988-78) 82804-988-90 90 TABLET in 1 BOTTLE (82804-988-90)

Ingredients (1)

dapsone (25 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": "9cfe5fe7-abc7-4f48-a597-1b1a5c70a354", "openfda": {"nui": ["N0000175881", "M0020791"], "upc": ["0382804989300", "0382804988303"], "unii": ["8W5C518302"], "rxcui": ["197557", "197558"], "spl_set_id": ["9cfe5fe7-abc7-4f48-a597-1b1a5c70a354"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (82804-988-00)", "package_ndc": "82804-988-00", "marketing_start_date": "20240521"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (82804-988-11)", "package_ndc": "82804-988-11", "marketing_start_date": "20240521"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-988-30)", "package_ndc": "82804-988-30", "marketing_start_date": "20240521"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (82804-988-55)", "package_ndc": "82804-988-55", "marketing_start_date": "20240521"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (82804-988-60)", "package_ndc": "82804-988-60", "marketing_start_date": "20240521"}, {"sample": false, "description": "240 TABLET in 1 BOTTLE (82804-988-64)", "package_ndc": "82804-988-64", "marketing_start_date": "20240521"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (82804-988-72)", "package_ndc": "82804-988-72", "marketing_start_date": "20240521"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (82804-988-78)", "package_ndc": "82804-988-78", "marketing_start_date": "20240521"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-988-90)", "package_ndc": "82804-988-90", "marketing_start_date": "20240521"}], "brand_name": "Dapsone", "product_id": "82804-988_9cfe5fe7-abc7-4f48-a597-1b1a5c70a354", "dosage_form": "TABLET", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "82804-988", "generic_name": "Dapsone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "25 mg/1"}], "application_number": "ANDA086841", "marketing_category": "ANDA", "marketing_start_date": "20240116", "listing_expiration_date": "20261231"}