dapsone

Generic: dapsone

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

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dapsone 25 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-965
Product ID 62135-965_33eb8d96-1ab4-2d54-e063-6294a90a9339
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204074
Listing Expiration 2026-12-31
Marketing Start 2016-05-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135965
Hyphenated Format 62135-965

Supplemental Identifiers

RxCUI
197557 197558
UPC
0362135966300 0362135965303
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 ANDA204074 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62135-965-30)
source: ndc

Packages (1)

62135-965-30 30 TABLET in 1 BOTTLE (62135-965-30)

Ingredients (1)

dapsone (25 mg/1)

Linked Drug Pages (1)

Dapsone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "33eb8d96-1ab4-2d54-e063-6294a90a9339", "openfda": {"nui": ["N0000175881", "M0020791"], "upc": ["0362135966300", "0362135965303"], "unii": ["8W5C518302"], "rxcui": ["197557", "197558"], "spl_set_id": ["93028aff-54f0-4f94-b925-a91400118294"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62135-965-30)", "package_ndc": "62135-965-30", "marketing_start_date": "20250408"}], "brand_name": "Dapsone", "product_id": "62135-965_33eb8d96-1ab4-2d54-e063-6294a90a9339", "dosage_form": "TABLET", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "62135-965", "generic_name": "Dapsone", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "25 mg/1"}], "application_number": "ANDA204074", "marketing_category": "ANDA", "marketing_start_date": "20160510", "listing_expiration_date": "20261231"}