NDC 57277-107

Carboplatin

Carboplatin Injection

Carboplatin is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Sanja Pharmaceuticals Company. The primary component is Carboplatin.

Product ID57277-107_09c0db7d-1392-4d2b-9fca-07e8272df7de
NDC57277-107
Product TypeHuman Prescription Drug
Proprietary NameCarboplatin
Generic NameCarboplatin Injection
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-09-29
Marketing CategoryANDA / ANDA
Application NumberANDA205487
Labeler NameSanja Pharmaceuticals Company
Substance NameCARBOPLATIN
Active Ingredient Strength450 mg/5mL
Pharm ClassesPlatinum-containing Compounds [EXT],Platinum-based Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57277-107-45

1 VIAL, MULTI-DOSE in 1 CARTON (57277-107-45) > 5 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2016-09-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57277-107-45 [57277010745]

Carboplatin SOLUTION
Marketing CategoryANDA
Application NumberANDA205487
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CARBOPLATIN450 mg/5mL

OpenFDA Data

SPL SET ID:f4baa639-287b-4d97-923f-ce5c6add531c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 597195
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Carboplatin" or generic name "Carboplatin Injection"

    NDCBrand NameGeneric Name
    0703-4239CarboplatinCarboplatin
    0703-4244CarboplatinCarboplatin
    0703-4246CarboplatinCarboplatin
    0703-4248CarboplatinCarboplatin
    16729-295CarboplatinCarboplatin
    25021-202Carboplatincarboplatin
    47335-284carboplatincarboplatin
    47781-603CARBOPLATINCarboplatin
    47781-604CARBOPLATINCarboplatin
    47781-605CARBOPLATINCarboplatin
    47781-606CARBOPLATINCarboplatin
    50742-445CarboplatinCarboplatin
    50742-446CarboplatinCarboplatin
    50742-447CarboplatinCarboplatin
    50742-448CarboplatinCarboplatin
    55150-333CARBOPLATINCARBOPLATIN
    55150-334CARBOPLATINCARBOPLATIN
    55150-335CARBOPLATINCARBOPLATIN
    55150-386CARBOPLATINCARBOPLATIN
    57277-105Carboplatincarboplatin Injection
    68083-190CARBOPLATINCARBOPLATIN
    68083-192CARBOPLATINCARBOPLATIN
    68083-191CARBOPLATINCARBOPLATIN
    68083-193CARBOPLATINCARBOPLATIN
    69097-241CARBOPLATINCARBOPLATIN
    69097-242CARBOPLATINCARBOPLATIN
    69097-239CARBOPLATINCARBOPLATIN
    69097-243CARBOPLATINCARBOPLATIN
    71288-100CarboplatinCarboplatin
    57277-106CarboplatinCarboplatin
    57277-107CarboplatinCarboplatin
    61703-339CarboplatinCarboplatin
    63323-172CarboplatinCarboplatin
    66758-047CarboplatinCarboplatin

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