NDC 68387-450

Silver Sulfadiazine

Silver Sulfadiazine

Silver Sulfadiazine is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Keltman Pharmaceuticals Inc.. The primary component is Silver Sulfadiazine.

Product ID68387-450_36c67b60-9529-4f19-a4b8-b68788f836c1
NDC68387-450
Product TypeHuman Prescription Drug
Proprietary NameSilver Sulfadiazine
Generic NameSilver Sulfadiazine
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2007-03-10
Marketing CategoryANDA / ANDA
Application NumberANDA018578
Labeler NameKeltman Pharmaceuticals Inc.
Substance NameSILVER SULFADIAZINE
Active Ingredient Strength10 mg/g
Pharm ClassesSulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68387-450-01

50 g in 1 JAR (68387-450-01)
Marketing Start Date2007-03-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68387-450-01 [68387045001]

Silver Sulfadiazine CREAM
Marketing CategoryANDA
Application NumberANDA018578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2007-03-10
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
SILVER SULFADIAZINE10 mg/g

OpenFDA Data

SPL SET ID:27c5999a-0bbe-4d20-9a9e-3546c8189ae3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 106351
  • Pharmacological Class

    • Sulfonamide Antibacterial [EPC]
    • Sulfonamides [CS]

    NDC Crossover Matching brand name "Silver Sulfadiazine" or generic name "Silver Sulfadiazine"

    NDCBrand NameGeneric Name
    0440-0124Silver SulfadiazineSilver Sulfadiazine
    33261-589Silver SulfadiazineSilver Sulfadiazine
    45865-642Silver SulfadiazineSilver Sulfadiazine
    49999-185Silver SulfadiazineSilver Sulfadiazine
    50090-0607Silver SulfadiazineSilver Sulfadiazine
    50090-0717Silver SulfadiazineSilver Sulfadiazine
    50090-0763Silver SulfadiazineSilver Sulfadiazine
    50090-2152Silver SulfadiazineSilver Sulfadiazine
    50436-1240Silver SulfadiazineSilver Sulfadiazine
    52959-635Silver SulfadiazineSilver Sulfadiazine
    53002-9090Silver SulfadiazineSilver Sulfadiazine
    55700-068Silver SulfadiazineSilver Sulfadiazine
    59762-0131SILVER SULFADIAZINEsilver sulfadiazine
    61919-206SILVER SULFADIAZINESILVER SULFADAZINE
    61919-237Silver SulfadiazineSilver Sulfadiazine
    63187-023Silver SulfadiazineSilver Sulfadiazine
    67877-124Silver SulfadiazineSilver Sulfadiazine
    68071-1334Silver SulfadiazineSilver Sulfadiazine
    68071-1333Silver SulfadiazineSilver Sulfadiazine
    68071-4481Silver SulfadiazineSilver Sulfadiazine
    68387-450Silver SulfadiazineSilver Sulfadiazine
    70518-0366Silver SulfadiazineSilver Sulfadiazine
    70518-1562Silver SulfadiazineSilver Sulfadiazine
    66267-943Silver SulfadiazineSilver Sulfadiazine
    49999-143SILVADENEsilver sulfadiazine
    50090-0230SILVADENEsilver sulfadiazine
    61570-131SILVADENEsilver sulfadiazine
    0591-0810Silver SulfadiazeneSilver Sulfadiazine
    42254-118Silver SulfadiazeneSilver Sulfadiazine
    50436-3098Silver SulfadiazeneSilver Sulfadiazine
    50436-3099Silver SulfadiazeneSilver Sulfadiazine
    43598-210SSD CreamSilver Sulfadiazine
    50090-2288SSD CreamSilver Sulfadiazine
    55700-640SSD CreamSilver Sulfadiazine
    21695-182ThermazeneSilver Sulfadiazine
    53097-101ThermazeneSilver Sulfadiazine

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