dapsone

Generic: dapsone

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dapsone 25 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-567
Product ID 64980-567_e1aaf1ed-de8a-4c31-85de-68d728c95e86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207165
Listing Expiration 2027-12-31
Marketing Start 2023-07-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980567
Hyphenated Format 64980-567

Supplemental Identifiers

RxCUI
197557 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 ANDA207165 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64980-567-01)
  • 30 TABLET in 1 BOTTLE (64980-567-03)
source: ndc

Packages (2)

64980-567-01 100 TABLET in 1 BOTTLE (64980-567-01) 64980-567-03 30 TABLET in 1 BOTTLE (64980-567-03)

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": "e1aaf1ed-de8a-4c31-85de-68d728c95e86", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["197557", "197558"], "spl_set_id": ["e369b26d-219a-4e23-b8d4-f94048d36acd"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64980-567-01)", "package_ndc": "64980-567-01", "marketing_start_date": "20230720"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (64980-567-03)", "package_ndc": "64980-567-03", "marketing_start_date": "20230829"}], "brand_name": "Dapsone", "product_id": "64980-567_e1aaf1ed-de8a-4c31-85de-68d728c95e86", "dosage_form": "TABLET", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "64980-567", "generic_name": "dapsone", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "25 mg/1"}], "application_number": "ANDA207165", "marketing_category": "ANDA", "marketing_start_date": "20230720", "listing_expiration_date": "20271231"}