dapsone

Generic: dapsone

Labeler: mayne pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler mayne pharma
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

dapsone 50 mg/g

Manufacturer
Mayne Pharma

Identifiers & Regulatory

Product NDC 51862-123
Product ID 51862-123_45c41a7a-58d6-48fd-bfe3-f9bc9508c335
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212383
Listing Expiration 2026-12-31
Marketing Start 2024-02-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862123
Hyphenated Format 51862-123

Supplemental Identifiers

RxCUI
607295
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 ANDA212383 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51862-123-60) / 60 g in 1 TUBE
source: ndc

Packages (1)

51862-123-60 1 TUBE in 1 CARTON (51862-123-60) / 60 g in 1 TUBE

Ingredients (1)

dapsone (50 mg/g)

Linked Drug Pages (1)

Dapsone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "45c41a7a-58d6-48fd-bfe3-f9bc9508c335", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["607295"], "spl_set_id": ["dc495e54-8917-42de-a9fa-1f961bd99d61"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Mayne Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51862-123-60)  / 60 g in 1 TUBE", "package_ndc": "51862-123-60", "marketing_start_date": "20240214"}], "brand_name": "Dapsone", "product_id": "51862-123_45c41a7a-58d6-48fd-bfe3-f9bc9508c335", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "51862-123", "generic_name": "Dapsone", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "50 mg/g"}], "application_number": "ANDA212383", "marketing_category": "ANDA", "marketing_start_date": "20240214", "listing_expiration_date": "20261231"}