dapsone

Generic: dapsone

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

Drug Facts

Product Profile

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

dapsone 75 mg/g

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4830
Product ID 0378-4830_9feeeb14-77f7-47c7-816f-515ea0a60463
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213847
Listing Expiration 2026-12-31
Marketing Start 2022-05-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03784830
Hyphenated Format 0378-4830

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 ANDA213847 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (0378-4830-60) / 60 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (0378-4830-90) / 90 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

0378-4830-60 1 BOTTLE, PUMP in 1 CARTON (0378-4830-60) / 60 g in 1 BOTTLE, PUMP 0378-4830-90 1 BOTTLE, PUMP in 1 CARTON (0378-4830-90) / 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": "9feeeb14-77f7-47c7-816f-515ea0a60463", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["1741905"], "spl_set_id": ["e04da0a1-d02a-487d-a931-a31034738fdd"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0378-4830-60)  / 60 g in 1 BOTTLE, PUMP", "package_ndc": "0378-4830-60", "marketing_start_date": "20220520"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0378-4830-90)  / 90 g in 1 BOTTLE, PUMP", "package_ndc": "0378-4830-90", "marketing_start_date": "20220520"}], "brand_name": "Dapsone", "product_id": "0378-4830_9feeeb14-77f7-47c7-816f-515ea0a60463", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "0378-4830", "generic_name": "Dapsone", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "75 mg/g"}], "application_number": "ANDA213847", "marketing_category": "ANDA", "marketing_start_date": "20220520", "listing_expiration_date": "20261231"}