NDC 68083-191

CARBOPLATIN

Carboplatin

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

Product ID68083-191_f171db85-7a96-42ae-a443-f31586f94803
NDC68083-191
Product TypeHuman Prescription Drug
Proprietary NameCARBOPLATIN
Generic NameCarboplatin
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-02-20
Marketing CategoryANDA / ANDA
Application NumberANDA207324
Labeler NameGland Pharma Limited
Substance NameCARBOPLATIN
Active Ingredient Strength10 mg/mL
Pharm ClassesPlatinum-containing Compounds [EXT],Platinum-based Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-191-01

1 VIAL, MULTI-DOSE in 1 CARTON (68083-191-01) > 15 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2017-02-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-191-01 [68083019101]

CARBOPLATIN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207324
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-20

Drug Details

Active Ingredients

IngredientStrength
CARBOPLATIN10 mg/mL

OpenFDA Data

SPL SET ID:9eb057eb-29ce-40d2-9ac8-ed107f25f5ab
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 597195
  • Pharmacological Class

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

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

    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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