dapsone

Generic: dapsone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapsone
Generic Name dapsone
Labeler sun pharmaceutical industries, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

dapsone 75 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1388
Product ID 51672-1388_38efc7a1-c4c6-61ad-e063-6294a90af18b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210191
Listing Expiration 2026-12-31
Marketing Start 2019-06-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721388
Hyphenated Format 51672-1388

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 ANDA210191 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (51672-1388-2) / 30 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (51672-1388-3) / 60 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (51672-1388-8) / 90 g in 1 BOTTLE, PUMP
source: ndc

Packages (3)

51672-1388-2 1 BOTTLE, PUMP in 1 CARTON (51672-1388-2) / 30 g in 1 BOTTLE, PUMP 51672-1388-3 1 BOTTLE, PUMP in 1 CARTON (51672-1388-3) / 60 g in 1 BOTTLE, PUMP 51672-1388-8 1 BOTTLE, PUMP in 1 CARTON (51672-1388-8) / 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": "38efc7a1-c4c6-61ad-e063-6294a90af18b", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["1741905"], "spl_set_id": ["32fcb7e0-5a6d-4d95-b81c-148012a54112"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (51672-1388-2)  / 30 g in 1 BOTTLE, PUMP", "package_ndc": "51672-1388-2", "marketing_start_date": "20190626"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (51672-1388-3)  / 60 g in 1 BOTTLE, PUMP", "package_ndc": "51672-1388-3", "marketing_start_date": "20190626"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (51672-1388-8)  / 90 g in 1 BOTTLE, PUMP", "package_ndc": "51672-1388-8", "marketing_start_date": "20190626"}], "brand_name": "Dapsone", "product_id": "51672-1388_38efc7a1-c4c6-61ad-e063-6294a90af18b", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "51672-1388", "generic_name": "Dapsone", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "75 mg/g"}], "application_number": "ANDA210191", "marketing_category": "ANDA", "marketing_start_date": "20190626", "listing_expiration_date": "20261231"}