dapsone

Generic: dapsone

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dapsone 25 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-135
Product ID 70954-135_846ff8b6-d395-4e67-98ea-9dbfd688b97e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206505
Listing Expiration 2026-12-31
Marketing Start 2018-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954135
Hyphenated Format 70954-135

Supplemental Identifiers

RxCUI
197557 197558
UPC
0370954135104 0370954136200 0370954135203 0370954136101
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 ANDA206505 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70954-135-10)
  • 100 TABLET in 1 BOTTLE (70954-135-20)
source: ndc

Packages (2)

70954-135-10 30 TABLET in 1 BOTTLE (70954-135-10) 70954-135-20 100 TABLET in 1 BOTTLE (70954-135-20)

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": "846ff8b6-d395-4e67-98ea-9dbfd688b97e", "openfda": {"nui": ["N0000175881", "M0020791"], "upc": ["0370954135104", "0370954136200", "0370954135203", "0370954136101"], "unii": ["8W5C518302"], "rxcui": ["197557", "197558"], "spl_set_id": ["57a47368-d1f6-4d61-a2ee-c5f1fe7ff690"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70954-135-10)", "package_ndc": "70954-135-10", "marketing_start_date": "20180115"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-135-20)", "package_ndc": "70954-135-20", "marketing_start_date": "20180115"}], "brand_name": "DAPSONE", "product_id": "70954-135_846ff8b6-d395-4e67-98ea-9dbfd688b97e", "dosage_form": "TABLET", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "70954-135", "generic_name": "Dapsone", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DAPSONE", "active_ingredients": [{"name": "DAPSONE", "strength": "25 mg/1"}], "application_number": "ANDA206505", "marketing_category": "ANDA", "marketing_start_date": "20180115", "listing_expiration_date": "20261231"}