NDC 45963-611

Oxaliplatin

Oxaliplatin

Oxaliplatin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Oxaliplatin.

Product ID45963-611_1fd2120a-d9e8-40d1-aeed-8745756ac00c
NDC45963-611
Product TypeHuman Prescription Drug
Proprietary NameOxaliplatin
Generic NameOxaliplatin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-01-05
Marketing CategoryANDA / ANDA
Application NumberANDA078803
Labeler NameActavis Pharma, Inc.
Substance NameOXALIPLATIN
Active Ingredient Strength5 mg/mL
Pharm ClassesPlatinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 45963-611-53

1 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-53) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2015-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-611-59 [45963061159]

Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA078803
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-05

NDC 45963-611-53 [45963061153]

Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA078803
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-05

Drug Details

Active Ingredients

IngredientStrength
OXALIPLATIN5 mg/mL

OpenFDA Data

SPL SET ID:78f6a5f3-d088-4aee-9743-fa8cf19d3d75
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1736784
  • 1736786
  • Pharmacological Class

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