dapsone

Generic: dapsone

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler alembic pharmaceuticals limited
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

dapsone 75 mg/g

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-663
Product ID 46708-663_f201a2ad-d969-428f-bb66-13401c124c0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215718
Listing Expiration 2026-12-31
Marketing Start 2023-10-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708663
Hyphenated Format 46708-663

Supplemental Identifiers

RxCUI
1741905
UPC
0346708663308
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 ANDA215718 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (46708-663-30) / 30 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (46708-663-60) / 60 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (46708-663-90) / 90 g in 1 BOTTLE, PUMP
source: ndc

Packages (3)

46708-663-30 1 BOTTLE, PUMP in 1 CARTON (46708-663-30) / 30 g in 1 BOTTLE, PUMP 46708-663-60 1 BOTTLE, PUMP in 1 CARTON (46708-663-60) / 60 g in 1 BOTTLE, PUMP 46708-663-90 1 BOTTLE, PUMP in 1 CARTON (46708-663-90) / 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": "f201a2ad-d969-428f-bb66-13401c124c0a", "openfda": {"nui": ["N0000175881", "M0020791"], "upc": ["0346708663308"], "unii": ["8W5C518302"], "rxcui": ["1741905"], "spl_set_id": ["d71eba65-3d78-4252-acb8-90eea60921d1"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (46708-663-30)  / 30 g in 1 BOTTLE, PUMP", "package_ndc": "46708-663-30", "marketing_start_date": "20231030"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (46708-663-60)  / 60 g in 1 BOTTLE, PUMP", "package_ndc": "46708-663-60", "marketing_start_date": "20231030"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (46708-663-90)  / 90 g in 1 BOTTLE, PUMP", "package_ndc": "46708-663-90", "marketing_start_date": "20231030"}], "brand_name": "Dapsone", "product_id": "46708-663_f201a2ad-d969-428f-bb66-13401c124c0a", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "46708-663", "generic_name": "Dapsone", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "75 mg/g"}], "application_number": "ANDA215718", "marketing_category": "ANDA", "marketing_start_date": "20231030", "listing_expiration_date": "20261231"}