dapsone

Generic: dapsone

Labeler: taro pharmaceuticals u.s.a., inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler taro pharmaceuticals u.s.a., inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dapsone 25 mg/1

Manufacturer
Taro Pharmaceuticals U.S.A., Inc.

Identifiers & Regulatory

Product NDC 51672-4197
Product ID 51672-4197_e93b86ed-7d01-4de9-b670-2955005676f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209430
Listing Expiration 2026-12-31
Marketing Start 2019-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516724197
Hyphenated Format 51672-4197

Supplemental Identifiers

RxCUI
197557 197558
UPC
0351672419769 0351672419868
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 ANDA209430 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (51672-4197-2) / 15 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (51672-4197-6)
source: ndc

Packages (2)

51672-4197-2 2 BLISTER PACK in 1 CARTON (51672-4197-2) / 15 TABLET in 1 BLISTER PACK 51672-4197-6 30 TABLET in 1 BOTTLE (51672-4197-6)

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": "e93b86ed-7d01-4de9-b670-2955005676f3", "openfda": {"nui": ["N0000175881", "M0020791"], "upc": ["0351672419769", "0351672419868"], "unii": ["8W5C518302"], "rxcui": ["197557", "197558"], "spl_set_id": ["cb312185-b9f1-4fa4-9481-bcf5d9bb3edf"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Taro Pharmaceuticals U.S.A., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51672-4197-2)  / 15 TABLET in 1 BLISTER PACK", "package_ndc": "51672-4197-2", "marketing_start_date": "20190301"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (51672-4197-6)", "package_ndc": "51672-4197-6", "marketing_start_date": "20190301"}], "brand_name": "Dapsone", "product_id": "51672-4197_e93b86ed-7d01-4de9-b670-2955005676f3", "dosage_form": "TABLET", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "51672-4197", "generic_name": "Dapsone", "labeler_name": "Taro Pharmaceuticals U.S.A., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "25 mg/1"}], "application_number": "ANDA209430", "marketing_category": "ANDA", "marketing_start_date": "20190301", "listing_expiration_date": "20261231"}