dapsone

Generic: dapsone

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

Drug Facts

Product Profile

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

dapsone 75 mg/g

Manufacturer
Mayne Pharma Commercial LLC

Identifiers & Regulatory

Product NDC 68308-342
Product ID 68308-342_2aca889b-4e07-496c-aba0-02a5c0cea041
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214722
Listing Expiration 2026-12-31
Marketing Start 2022-02-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308342
Hyphenated Format 68308-342

Supplemental Identifiers

RxCUI
1741905
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 ANDA214722 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (68308-342-60) / 60 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (68308-342-90) / 90 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

68308-342-60 1 BOTTLE, PUMP in 1 CARTON (68308-342-60) / 60 g in 1 BOTTLE, PUMP 68308-342-90 1 BOTTLE, PUMP in 1 CARTON (68308-342-90) / 90 g in 1 BOTTLE, PUMP

Ingredients (1)

dapsone (75 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": "2aca889b-4e07-496c-aba0-02a5c0cea041", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["1741905"], "spl_set_id": ["cbf9e81e-00ef-4218-975e-6a1610b7f1dd"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Mayne Pharma Commercial LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68308-342-60)  / 60 g in 1 BOTTLE, PUMP", "package_ndc": "68308-342-60", "marketing_start_date": "20220211"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68308-342-90)  / 90 g in 1 BOTTLE, PUMP", "package_ndc": "68308-342-90", "marketing_start_date": "20220211"}], "brand_name": "Dapsone", "product_id": "68308-342_2aca889b-4e07-496c-aba0-02a5c0cea041", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "68308-342", "generic_name": "Dapsone", "labeler_name": "Mayne Pharma Commercial LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "75 mg/g"}], "application_number": "ANDA214722", "marketing_category": "ANDA", "marketing_start_date": "20220211", "listing_expiration_date": "20261231"}