NDC 47335-178

Oxaliplatin

Oxaliplatin

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

Product ID47335-178_47ebaf59-b7c2-4f6b-bf3e-292da264662c
NDC47335-178
Product TypeHuman Prescription Drug
Proprietary NameOxaliplatin
Generic NameOxaliplatin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2009-08-19
Marketing CategoryANDA / ANDA
Application NumberANDA078818
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameOXALIPLATIN
Active Ingredient Strength100 mg/20mL
Pharm ClassesPlatinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 47335-178-40

1 VIAL, SINGLE-USE in 1 CARTON (47335-178-40) > 20 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2009-08-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-178-40 [47335017840]

Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA078818
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-19
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OXALIPLATIN100 mg/20mL

OpenFDA Data

SPL SET ID:8efb4c07-455b-4c91-b257-6fd43854454c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1736784
  • 1736786
  • UPC Code
  • 0347335178401
  • 0347335176407
  • 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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