dapsone

Generic: dapsone

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler zydus lifesciences limited
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

dapsone 75 mg/g

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1538
Product ID 70771-1538_ae448df2-611f-4d56-911f-11d01983726f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214019
Listing Expiration 2026-12-31
Marketing Start 2024-05-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711538
Hyphenated Format 70771-1538

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 ANDA214019 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (70771-1538-2) / 30 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (70771-1538-3) / 60 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (70771-1538-8) / 90 g in 1 BOTTLE, PUMP
source: ndc

Packages (3)

70771-1538-2 1 BOTTLE, PUMP in 1 CARTON (70771-1538-2) / 30 g in 1 BOTTLE, PUMP 70771-1538-3 1 BOTTLE, PUMP in 1 CARTON (70771-1538-3) / 60 g in 1 BOTTLE, PUMP 70771-1538-8 1 BOTTLE, PUMP in 1 CARTON (70771-1538-8) / 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": "ae448df2-611f-4d56-911f-11d01983726f", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["1741905"], "spl_set_id": ["8b63b653-0507-4f95-9bfa-70fd071e15a6"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (70771-1538-2)  / 30 g in 1 BOTTLE, PUMP", "package_ndc": "70771-1538-2", "marketing_start_date": "20240510"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (70771-1538-3)  / 60 g in 1 BOTTLE, PUMP", "package_ndc": "70771-1538-3", "marketing_start_date": "20240510"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (70771-1538-8)  / 90 g in 1 BOTTLE, PUMP", "package_ndc": "70771-1538-8", "marketing_start_date": "20240510"}], "brand_name": "Dapsone", "product_id": "70771-1538_ae448df2-611f-4d56-911f-11d01983726f", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "70771-1538", "generic_name": "Dapsone", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "75 mg/g"}], "application_number": "ANDA214019", "marketing_category": "ANDA", "marketing_start_date": "20240510", "listing_expiration_date": "20261231"}