dapsone

Generic: dapsone

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler amneal pharmaceuticals llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

dapsone 50 mg/g

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-339
Product ID 65162-339_e09d2bfe-ca6f-4f12-ba61-993371b94478
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209890
Listing Expiration 2026-12-31
Marketing Start 2023-10-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162339
Hyphenated Format 65162-339

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 ANDA209890 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (65162-339-63) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (65162-339-85) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (65162-339-91) / 90 g in 1 TUBE
source: ndc

Packages (3)

65162-339-63 1 TUBE in 1 CARTON (65162-339-63) / 30 g in 1 TUBE 65162-339-85 1 TUBE in 1 CARTON (65162-339-85) / 60 g in 1 TUBE 65162-339-91 1 TUBE in 1 CARTON (65162-339-91) / 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": "e09d2bfe-ca6f-4f12-ba61-993371b94478", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["607295"], "spl_set_id": ["f3e33970-ac11-4bb6-9f39-6f58d86fdefb"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (65162-339-63)  / 30 g in 1 TUBE", "package_ndc": "65162-339-63", "marketing_start_date": "20231024"}, {"sample": false, "description": "1 TUBE in 1 CARTON (65162-339-85)  / 60 g in 1 TUBE", "package_ndc": "65162-339-85", "marketing_start_date": "20231024"}, {"sample": false, "description": "1 TUBE in 1 CARTON (65162-339-91)  / 90 g in 1 TUBE", "package_ndc": "65162-339-91", "marketing_start_date": "20231024"}], "brand_name": "Dapsone", "product_id": "65162-339_e09d2bfe-ca6f-4f12-ba61-993371b94478", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "65162-339", "generic_name": "Dapsone", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "50 mg/g"}], "application_number": "ANDA209890", "marketing_category": "ANDA", "marketing_start_date": "20231024", "listing_expiration_date": "20261231"}