NDC 47781-610

Cisplatin

Cisplatin

Cisplatin is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Alvogen Inc.. The primary component is Cisplatin.

Product ID47781-610_4f1e86f3-8144-a1e9-6f03-cab6bebd2e13
NDC47781-610
Product TypeHuman Prescription Drug
Proprietary NameCisplatin
Generic NameCisplatin
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-09-25
Marketing CategoryANDA / ANDA
Application NumberANDA207323
Labeler NameAlvogen Inc.
Substance NameCISPLATIN
Active Ingredient Strength100 mg/100mL
Pharm ClassesPlatinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 47781-610-23

1 VIAL, MULTI-DOSE in 1 CARTON (47781-610-23) > 100 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2017-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47781-610-23 [47781061023]

Cisplatin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207323
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-09-25
Marketing End Date2020-03-01

Drug Details

Active Ingredients

IngredientStrength
CISPLATIN100 mg/100mL

OpenFDA Data

SPL SET ID:61fc9585-d1db-6c41-eb05-8c96d811b2ec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309311
  • Pharmacological Class

    • Platinum-based Drug [EPC]
    • Platinum-containing Compounds [EXT]

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

    NDCBrand NameGeneric Name
    0143-9504CISplatinCisplatin
    0143-9505CISplatinCisplatin
    0703-5747CisplatinCisplatin
    0703-5748CisplatinCisplatin
    16729-288CisplatinCisplatin
    44567-509CISplatinCISplatin
    44567-510CISplatinCISplatin
    44567-511CISplatinCISplatin
    44567-530Cisplatincisplatin
    47781-609Cisplatincisplatin
    47781-610Cisplatincisplatin
    63323-103CisplatinCISPLATIN
    68001-283CisplatinCisplatin
    68083-162CISPLATINCisplatin
    68083-163CISPLATINCisplatin
    70860-206Cisplatincisplatin
    61126-003Platinolcisplatin
    61126-004Platinol-AQcisplatin

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