NDC 0955-1731

OXALIPLATIN

Oxaliplatin

OXALIPLATIN is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Winthrop U.s.. The primary component is Oxaliplatin.

Product ID0955-1731_473bef8a-e927-454b-bc66-ec7403d4b45a
NDC0955-1731
Product TypeHuman Prescription Drug
Proprietary NameOXALIPLATIN
Generic NameOxaliplatin
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-09-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021759
Labeler NameWinthrop U.S.
Substance NameOXALIPLATIN
Active Ingredient Strength5 mg/mL
Pharm ClassesPlatinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0955-1731-10

1 VIAL, GLASS in 1 CARTON (0955-1731-10) > 10 mL in 1 VIAL, GLASS
Marketing Start Date2015-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0955-1731-10 [00955173110]

OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021759
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-09-01

Drug Details

Active Ingredients

IngredientStrength
OXALIPLATIN5 mg/mL

OpenFDA Data

SPL SET ID:70269278-fe61-4800-a064-32cb6845cc28
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1736781
  • 1736776
  • Pharmacological Class

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

    NDC Crossover Matching brand name "OXALIPLATIN" or generic name "Oxaliplatin"

    NDCBrand NameGeneric Name
    0703-3985OxaliplatinOxaliplatin
    0703-3986OxaliplatinOxaliplatin
    0781-3315OxaliplatinOxaliplatin
    0781-3317OxaliplatinOxaliplatin
    0781-9315OxaliplatinOxaliplatin
    0781-9317OxaliplatinOxaliplatin
    0955-1725OXALIPLATINoxaliplatin
    0955-1727OXALIPLATINoxaliplatin
    0955-1731OXALIPLATINoxaliplatin
    0955-1733OXALIPLATINoxaliplatin
    16714-727oxaliplatinoxaliplatin
    16714-728oxaliplatinoxaliplatin
    16729-332OXALIPLATINOXALIPLATIN
    68001-341oxaliplatinoxaliplatin
    68083-171OxaliplatinOxaliplatin
    68083-170OxaliplatinOxaliplatin
    68083-176OxaliplatinOxaliplatin
    68083-314OxaliplatinOxaliplatin
    68083-177OxaliplatinOxaliplatin
    69097-353oxaliplatinoxaliplatin
    69097-274oxaliplatinoxaliplatin
    70860-201OxaliplatinOxaliplatin
    71288-101OxaliplatinOxaliplatin
    72266-125OxaliplatinOxaliplatin
    72266-126OxaliplatinOxaliplatin
    25021-233oxaliplatinoxaliplatin
    43066-014OxaliplatinOxaliplatin
    43066-018OxaliplatinOxaliplatin
    45963-611OxaliplatinOxaliplatin
    47335-176OxaliplatinOxaliplatin
    47335-178OxaliplatinOxaliplatin
    47781-592OxaliplatinOxaliplatin
    45963-638OxaliplatinOxaliplatin
    45963-637OxaliplatinOxaliplatin
    47335-046OxaliplatinOxaliplatin
    47335-047OxaliplatinOxaliplatin
    47781-591OxaliplatinOxaliplatin
    50742-406OxaliplatinOxaliplatin
    50742-405OxaliplatinOxaliplatin
    51991-218OxaliplatinOxaliplatin
    51991-219OxaliplatinOxaliplatin
    51991-922OxaliplatinOxaliplatin
    51991-923OxaliplatinOxaliplatin
    57277-002OxaliplatinOxaliplatin
    57277-001OxaliplatinOxaliplatin
    60505-6132oxaliplatinoxaliplatin
    61703-363OxaliplatinOxaliplatin
    63323-750OxaliplatinOxaliplatin
    67184-0508OxaliplatinOxaliplatin
    67184-0509OxaliplatinOxaliplatin

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