dapsone

Generic: dapsone

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler cosette pharmaceuticals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

dapsone 50 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0886
Product ID 0713-0886_fb368415-d58a-0601-e053-6394a90a92af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210178
Listing Expiration 2026-12-31
Marketing Start 2023-05-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130886
Hyphenated Format 0713-0886

Supplemental Identifiers

RxCUI
607295
UPC
0307130886185 0307130886604
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 ANDA210178 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0713-0886-18) / 90 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0886-60) / 60 g in 1 TUBE
source: ndc

Packages (2)

0713-0886-18 1 TUBE in 1 CARTON (0713-0886-18) / 90 g in 1 TUBE 0713-0886-60 1 TUBE in 1 CARTON (0713-0886-60) / 60 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": "fb368415-d58a-0601-e053-6394a90a92af", "openfda": {"nui": ["N0000175881", "M0020791"], "upc": ["0307130886185", "0307130886604"], "unii": ["8W5C518302"], "rxcui": ["607295"], "spl_set_id": ["bc035edf-50d0-47ba-9b60-fe394ab3c32f"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0713-0886-18)  / 90 g in 1 TUBE", "package_ndc": "0713-0886-18", "marketing_start_date": "20230508"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0886-60)  / 60 g in 1 TUBE", "package_ndc": "0713-0886-60", "marketing_start_date": "20230508"}], "brand_name": "DAPSONE", "product_id": "0713-0886_fb368415-d58a-0601-e053-6394a90a92af", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "0713-0886", "generic_name": "dapsone", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DAPSONE", "active_ingredients": [{"name": "DAPSONE", "strength": "50 mg/g"}], "application_number": "ANDA210178", "marketing_category": "ANDA", "marketing_start_date": "20230508", "listing_expiration_date": "20261231"}