NDC 69097-353

oxaliplatin

Oxaliplatin

oxaliplatin is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Oxaliplatin.

Product ID69097-353_1f8ee714-a349-45a1-9b9a-337c16441498
NDC69097-353
Product TypeHuman Prescription Drug
Proprietary Nameoxaliplatin
Generic NameOxaliplatin
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-02-10
Marketing CategoryANDA / ANDA
Application NumberANDA208523
Labeler NameCipla USA Inc.
Substance NameOXALIPLATIN
Active Ingredient Strength100 mg/20mL
Pharm ClassesPlatinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69097-353-78

1 VIAL, SINGLE-DOSE in 1 CARTON (69097-353-78) > 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-02-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-353-78 [69097035378]

oxaliplatin INJECTION
Marketing CategoryANDA
Application NumberANDA208523
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-10

Drug Details

Active Ingredients

IngredientStrength
OXALIPLATIN5 mg/mL

OpenFDA Data

SPL SET ID:5ffb166a-8283-44c0-8590-ecad2743c154
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1736781
  • 1736776
  • UPC Code
  • 0369097353780
  • 0369097274375
  • 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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