NDC 63323-103

Cisplatin

Cisplatin

Cisplatin is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Cisplatin.

Product ID63323-103_1355b932-bdb6-4c06-b2db-b8dfdd0d6c6a
NDC63323-103
Product TypeHuman Prescription Drug
Proprietary NameCisplatin
Generic NameCisplatin
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2000-09-05
Marketing CategoryANDA / ANDA
Application NumberANDA074735
Labeler NameFresenius Kabi USA, LLC
Substance NameCISPLATIN
Active Ingredient Strength1 mg/mL
Pharm ClassesPlatinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-103-51

1 VIAL in 1 CARTON (63323-103-51) > 50 mL in 1 VIAL
Marketing Start Date2000-09-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-103-64 [63323010364]

Cisplatin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074735
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-09-05

NDC 63323-103-65 [63323010365]

Cisplatin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074735
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-09-05

NDC 63323-103-51 [63323010351]

Cisplatin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074735
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-09-05

Drug Details

Active Ingredients

IngredientStrength
CISPLATIN1 mg/mL

OpenFDA Data

SPL SET ID:de6302d5-85f0-4116-a709-57826c2c84fe
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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