dapsone

Generic: dapsone

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dapsone 25 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-008
Product ID 42291-008_484819b5-cdfe-b9fe-e063-6394a90a1880
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086841
Listing Expiration 2027-12-31
Marketing Start 2024-03-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291008
Hyphenated Format 42291-008

Supplemental Identifiers

RxCUI
197558
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 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 (42291-008-01)
source: ndc

Packages (1)

42291-008-01 100 TABLET in 1 BOTTLE (42291-008-01)

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": "484819b5-cdfe-b9fe-e063-6394a90a1880", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["197558"], "spl_set_id": ["13002250-b4c5-5890-e063-6394a90a2036"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42291-008-01)", "package_ndc": "42291-008-01", "marketing_start_date": "20240306"}], "brand_name": "Dapsone", "product_id": "42291-008_484819b5-cdfe-b9fe-e063-6394a90a1880", "dosage_form": "TABLET", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "42291-008", "generic_name": "Dapsone", "labeler_name": "AvKARE", "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": "20240306", "listing_expiration_date": "20271231"}