NDC 33261-589

Silver Sulfadiazine

Silver Sulfadiazine

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

Product ID33261-589_e5659b05-f4ad-4001-993f-6dec8a2dbf78
NDC33261-589
Product TypeHuman Prescription Drug
Proprietary NameSilver Sulfadiazine
Generic NameSilver Sulfadiazine
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2017-10-27
Marketing CategoryNDA / NDA
Application NumberNDA018810
Labeler NameAidarex Pharmaceuticals LLC
Substance NameSILVER SULFADIAZINE
Active Ingredient Strength10 mg/g
Pharm ClassesSulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 33261-589-01

25 g in 1 TUBE (33261-589-01)
Marketing Start Date2017-10-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-589-01 [33261058901]

Silver Sulfadiazine CREAM
Marketing CategoryNDA
Application NumberNDA018810
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-10-27
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SILVER SULFADIAZINE10 mg/g

OpenFDA Data

SPL SET ID:81e583ca-95a2-4382-b6e0-f147177a47ff
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.