NDC 68083-163

CISPLATIN

Cisplatin

CISPLATIN is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Cisplatin.

Product ID68083-163_5a24d5bd-c44a-43f7-a04c-76caf3475012
NDC68083-163
Product TypeHuman Prescription Drug
Proprietary NameCISPLATIN
Generic NameCisplatin
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-04-03
Marketing CategoryANDA / ANDA
Application NumberANDA207323
Labeler NameGland Pharma Limited
Substance NameCISPLATIN
Active Ingredient Strength1 mg/mL
Pharm ClassesPlatinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-163-01

1 VIAL in 1 CARTON (68083-163-01) > 100 mL in 1 VIAL
Marketing Start Date2017-04-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-163-01 [68083016301]

CISPLATIN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207323
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-03

Drug Details

Active Ingredients

IngredientStrength
CISPLATIN1 mg/mL

OpenFDA Data

SPL SET ID:a32820f7-9ff6-4c13-a96a-4483a943fe82
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309311
  • UPC Code
  • 0368083162016
  • 0368083163013
  • Pharmacological Class

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