dapsone

Generic: dapsone gel, 5%

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone gel, 5%
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

dapsone 50 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-018
Product ID 21922-018_4805ec1d-1a52-438d-8601-2878f5f40e08
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212383
Listing Expiration 2026-12-31
Marketing Start 2023-10-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922018
Hyphenated Format 21922-018

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 gel, 5% (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 (21922-018-07) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-018-08) / 90 g in 1 TUBE
source: ndc

Packages (2)

21922-018-07 1 TUBE in 1 CARTON (21922-018-07) / 60 g in 1 TUBE 21922-018-08 1 TUBE in 1 CARTON (21922-018-08) / 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": "4805ec1d-1a52-438d-8601-2878f5f40e08", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["607295"], "spl_set_id": ["4205a1a9-c459-47bb-9538-1dd559ca71f1"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-018-07)  / 60 g in 1 TUBE", "package_ndc": "21922-018-07", "marketing_start_date": "20231016"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-018-08)  / 90 g in 1 TUBE", "package_ndc": "21922-018-08", "marketing_start_date": "20231016"}], "brand_name": "Dapsone", "product_id": "21922-018_4805ec1d-1a52-438d-8601-2878f5f40e08", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "21922-018", "generic_name": "Dapsone Gel, 5%", "labeler_name": "Encube Ethicals, Inc.", "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": "20231016", "listing_expiration_date": "20261231"}