NDC 10135-655

DAPSONE

Dapsone

DAPSONE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Dapsone.

Product ID10135-655_afbef0ba-7481-405d-9219-62ec25d9a618
NDC10135-655
Product TypeHuman Prescription Drug
Proprietary NameDAPSONE
Generic NameDapsone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA206505
Labeler NameMarlex Pharmaceuticals Inc
Substance NameDAPSONE
Active Ingredient Strength100 mg/1
Pharm ClassesSulfone [EPC],Sulfones [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10135-655-01

100 TABLET in 1 BOTTLE (10135-655-01)
Marketing Start Date2018-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-655-01 [10135065501]

DAPSONE TABLET
Marketing CategoryANDA
Application NumberANDA206505
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-01
Inactivation Date2020-01-31

NDC 10135-655-30 [10135065530]

DAPSONE TABLET
Marketing CategoryANDA
Application NumberANDA206505
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DAPSONE100 mg/1

OpenFDA Data

SPL SET ID:6c2159ce-5ef2-418c-bb14-e58f55438f80
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197558
  • 197557
  • UPC Code
  • 0310135654017
  • Pharmacological Class

    • Sulfone [EPC]
    • Sulfones [CS]

    NDC Crossover Matching brand name "DAPSONE" or generic name "Dapsone"

    NDCBrand NameGeneric Name
    0378-4830DapsoneDapsone
    0904-7018DAPSONEDapsone
    0904-7019DAPSONEDapsone
    10135-654DAPSONEDapsone
    10135-655DAPSONEDapsone
    13668-605dapsonedapsone
    13925-504DapsoneDapsone
    13925-505DapsoneDapsone
    16714-956DapsoneDapsone
    29033-036DapsoneDapsone
    29033-037DapsoneDapsone
    42291-298DapsoneDapsone
    42291-299DapsoneDapsone
    43353-222DapsoneDapsone
    43353-223DapsoneDapsone
    47781-333Dapsonedapsone
    47781-334Dapsonedapsone
    49938-101DapsoneDapsone
    49938-102DapsoneDapsone
    51672-1387DapsoneDapsone
    51672-1388DapsoneDapsone
    51672-4197DapsoneDapsone
    68151-2693DapsoneDapsone
    69543-150DapsoneDapsone
    69543-151DapsoneDapsone
    70954-136DAPSONEDAPSONE
    70954-135DAPSONEDAPSONE
    51672-4198DapsoneDapsone
    55695-005DapsoneDapsone
    55695-025DapsoneDapsone
    60429-496DapsoneDapsone
    60429-495DapsoneDapsone
    60758-670DAPSONEDAPSONE
    51672-5307DapsoneDapsone
    0023-3670ACZONEdapsone
    0023-5206ACZONEdapsone
    16110-367ACZONEdapsone
    16110-526Aczonedapsone

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