dapsone

Generic: dapsone

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

Drug Facts

Product Profile

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

dapsone 75 mg/g

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-605
Product ID 13668-605_2c733874-9036-42d0-8820-d5a4a35b5adc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214722
Listing Expiration 2026-12-31
Marketing Start 2022-02-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668605
Hyphenated Format 13668-605

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 ANDA214722 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (13668-605-05) / 60 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (13668-605-08) / 90 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

13668-605-05 1 BOTTLE, PUMP in 1 CARTON (13668-605-05) / 60 g in 1 BOTTLE, PUMP 13668-605-08 1 BOTTLE, PUMP in 1 CARTON (13668-605-08) / 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": "2c733874-9036-42d0-8820-d5a4a35b5adc", "openfda": {"nui": ["N0000175881", "M0020791"], "unii": ["8W5C518302"], "rxcui": ["1741905"], "spl_set_id": ["f8cffc24-8310-4f21-ae77-7f6ad6095551"], "pharm_class_cs": ["Sulfones [CS]"], "pharm_class_epc": ["Sulfone [EPC]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (13668-605-05)  / 60 g in 1 BOTTLE, PUMP", "package_ndc": "13668-605-05", "marketing_start_date": "20220210"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (13668-605-08)  / 90 g in 1 BOTTLE, PUMP", "package_ndc": "13668-605-08", "marketing_start_date": "20220210"}], "brand_name": "dapsone", "product_id": "13668-605_2c733874-9036-42d0-8820-d5a4a35b5adc", "dosage_form": "GEL", "pharm_class": ["Sulfone [EPC]", "Sulfones [CS]"], "product_ndc": "13668-605", "generic_name": "dapsone", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "dapsone", "active_ingredients": [{"name": "DAPSONE", "strength": "75 mg/g"}], "application_number": "ANDA214722", "marketing_category": "ANDA", "marketing_start_date": "20220210", "listing_expiration_date": "20261231"}