NDC 0185-0757

Sulfadiazine

Sulfadiazine

Sulfadiazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Eon Labs, Inc.. The primary component is Sulfadiazine.

Product ID0185-0757_4435aed7-872c-4439-b5d7-4abd212f4a1e
NDC0185-0757
Product TypeHuman Prescription Drug
Proprietary NameSulfadiazine
Generic NameSulfadiazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1994-07-29
Marketing End Date2024-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA040091
Labeler NameEon Labs, Inc.
Substance NameSULFADIAZINE
Active Ingredient Strength500 mg/1
Pharm ClassesSulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC Exclude FlagN

Packaging

NDC 0185-0757-01

100 TABLET in 1 BOTTLE (0185-0757-01)
Marketing Start Date1994-07-29
Marketing End Date2024-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0185-0757-01 [00185075701]

Sulfadiazine TABLET
Marketing CategoryANDA
Application NumberANDA040091
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-07-29
Inactivation Date2020-01-31

NDC 0185-0757-30 [00185075730]

Sulfadiazine TABLET
Marketing CategoryANDA
Application NumberANDA040091
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-22
Marketing End Date2017-10-22
Inactivation Date2020-01-31

NDC 0185-0757-10 [00185075710]

Sulfadiazine TABLET
Marketing CategoryANDA
Application NumberANDA040091
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-07-29
Marketing End Date2017-12-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SULFADIAZINE500 mg/1

OpenFDA Data

SPL SET ID:10549cba-9c15-4d2e-a68c-5afbc178591d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198228
  • Pharmacological Class

    • Sulfonamide Antibacterial [EPC]
    • Sulfonamides [CS]

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

    NDCBrand NameGeneric Name
    0185-0757SulfadiazineSulfadiazine
    42806-757SULFADIAZINEsulfadiazine

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