NDC 68083-314

Oxaliplatin

Oxaliplatin

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

Product ID68083-314_14428c8b-0924-475c-ae35-a7363043cf5c
NDC68083-314
Product TypeHuman Prescription Drug
Proprietary NameOxaliplatin
Generic NameOxaliplatin
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-11-06
Marketing CategoryANDA / ANDA
Application NumberANDA207325
Labeler NameGland Pharma Limited
Substance NameOXALIPLATIN
Active Ingredient Strength5 mg/mL
Pharm ClassesPlatinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68083-314-01

1 VIAL, SINGLE-USE in 1 CARTON (68083-314-01) > 40 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2017-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-314-01 [68083031401]

Oxaliplatin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207325
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-06

Drug Details

Active Ingredients

IngredientStrength
OXALIPLATIN5 mg/mL

OpenFDA Data

SPL SET ID:a6f89dc3-a594-4b5b-8728-272e20c1ecb5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1736781
  • 1797528
  • 1736776
  • UPC Code
  • 0368083314019
  • 0368083176013
  • 0368083177010
  • 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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