dapsone

Generic: dapsone

Labeler: trupharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler trupharma, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

dapsone 75 mg/g

Manufacturer
Trupharma, LLC

Identifiers & Regulatory

Product NDC 52817-832
Product ID 52817-832_3e0fc779-85c7-f2b1-e063-6294a90adc6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213636
Listing Expiration 2026-12-31
Marketing Start 2024-11-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52817832
Hyphenated Format 52817-832

Supplemental Identifiers

RxCUI
1741905
UPC
0352817832900
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 ANDA213636 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (52817-832-60) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (52817-832-90) / 90 g in 1 TUBE
source: ndc

Packages (2)

52817-832-60 1 TUBE in 1 CARTON (52817-832-60) / 60 g in 1 TUBE 52817-832-90 1 TUBE in 1 CARTON (52817-832-90) / 90 g in 1 TUBE

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": "3e0fc779-85c7-f2b1-e063-6294a90adc6e", "openfda": {"nui": ["N0000175881", "M0020791"], "upc": ["0352817832900"], "unii": ["8W5C518302"], "rxcui": ["1741905"], "spl_set_id": ["2763bcbb-e249-be2b-e063-6394a90a5015"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Trupharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (52817-832-60)  / 60 g in 1 TUBE", "package_ndc": "52817-832-60", "marketing_start_date": "20241120"}, {"sample": false, "description": "1 TUBE in 1 CARTON (52817-832-90)  / 90 g in 1 TUBE", "package_ndc": "52817-832-90", "marketing_start_date": "20241120"}], "brand_name": "Dapsone", "product_id": "52817-832_3e0fc779-85c7-f2b1-e063-6294a90adc6e", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "52817-832", "generic_name": "Dapsone", "labeler_name": "Trupharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "75 mg/g"}], "application_number": "ANDA213636", "marketing_category": "ANDA", "marketing_start_date": "20241120", "listing_expiration_date": "20261231"}