dapsone

Generic: dapsone

Labeler: pacific pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler pacific pharma, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

dapsone 50 mg/g

Manufacturer
Pacific Pharma, Inc.

Identifiers & Regulatory

Product NDC 60758-670
Product ID 60758-670_41079403-219e-4194-90e8-3b9b83dcf298
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021794
Listing Expiration 2026-12-31
Marketing Start 2017-10-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60758670
Hyphenated Format 60758-670

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 NDA021794 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (60758-670-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (60758-670-60) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (60758-670-90) / 90 g in 1 TUBE
source: ndc

Packages (3)

60758-670-30 1 TUBE in 1 CARTON (60758-670-30) / 30 g in 1 TUBE 60758-670-60 1 TUBE in 1 CARTON (60758-670-60) / 60 g in 1 TUBE 60758-670-90 1 TUBE in 1 CARTON (60758-670-90) / 90 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": "41079403-219e-4194-90e8-3b9b83dcf298", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["607295"], "spl_set_id": ["8dbe1a41-6d9d-414f-aa9c-09bd95857e2a"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Pacific Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (60758-670-30)  / 30 g in 1 TUBE", "package_ndc": "60758-670-30", "marketing_start_date": "20171018"}, {"sample": false, "description": "1 TUBE in 1 CARTON (60758-670-60)  / 60 g in 1 TUBE", "package_ndc": "60758-670-60", "marketing_start_date": "20171018"}, {"sample": false, "description": "1 TUBE in 1 CARTON (60758-670-90)  / 90 g in 1 TUBE", "package_ndc": "60758-670-90", "marketing_start_date": "20171018"}], "brand_name": "DAPSONE", "product_id": "60758-670_41079403-219e-4194-90e8-3b9b83dcf298", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "60758-670", "generic_name": "dapsone", "labeler_name": "Pacific Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DAPSONE", "active_ingredients": [{"name": "DAPSONE", "strength": "50 mg/g"}], "application_number": "NDA021794", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20171018", "listing_expiration_date": "20261231"}