NDC 16729-332

OXALIPLATIN

Oxaliplatin

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

Product ID16729-332_6cdab070-09f2-1771-e053-2991aa0a33f9
NDC16729-332
Product TypeHuman Prescription Drug
Proprietary NameOXALIPLATIN
Generic NameOxaliplatin
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-05-17
Marketing CategoryANDA / ANDA
Application NumberANDA207474
Labeler NameAccord Healthcare Inc.
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 16729-332-03

1 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-03) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-332-05 [16729033205]

OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA207474
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-17

NDC 16729-332-03 [16729033203]

OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA207474
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-17

Drug Details

Active Ingredients

IngredientStrength
OXALIPLATIN5 mg/mL

OpenFDA Data

SPL SET ID:4b805925-beb1-2bac-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1736781
  • 1797528
  • 1736776
  • UPC Code
  • 0316729332057
  • 0316729332033
  • 0316729332354
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.