NDC 63323-637

Arsenic Trioxide

Arsenic Trioxide

Arsenic Trioxide is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Arsenic Trioxide.

Product ID63323-637_079d7fc3-9b8d-4983-a894-b86b6ff3d6aa
NDC63323-637
Product TypeHuman Prescription Drug
Proprietary NameArsenic Trioxide
Generic NameArsenic Trioxide
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA208231
Labeler NameFresenius Kabi USA, LLC
Substance NameARSENIC TRIOXIDE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63323-637-10

10 VIAL, SINGLE-DOSE in 1 CARTON (63323-637-10) > 10 mL in 1 VIAL, SINGLE-DOSE (63323-637-03)
Marketing Start Date2018-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-637-03 [63323063703]

Arsenic Trioxide INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA208231
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-08-31

NDC 63323-637-10 [63323063710]

Arsenic Trioxide INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA208231
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-08-31

Drug Details

Active Ingredients

IngredientStrength
ARSENIC TRIOXIDE1 mg/mL

OpenFDA Data

SPL SET ID:a482eccd-8837-47ea-904d-2f2c294d10fa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 829926
  • NDC Crossover Matching brand name "Arsenic Trioxide" or generic name "Arsenic Trioxide"

    NDCBrand NameGeneric Name
    0781-3498Arsenic TrioxideArsenic Trioxide
    14789-600Arsenic TrioxideArsenic Trioxide
    49315-005Arsenic trioxideArsenic trioxide
    49315-007Arsenic trioxideArsenic trioxide
    50742-438ARSENIC TRIOXIDEarsenic trioxide
    50742-525ARSENIC TRIOXIDEarsenic trioxide
    68382-997Arsenic trioxideArsenic trioxide
    69918-720ARSENIC TRIOXIDEARSENIC TRIOXIDE
    63323-637Arsenic TrioxideArsenic Trioxide
    54879-027Arsenic TrioxideArsenic Trioxide
    70710-1610Arsenic trioxideArsenic trioxide
    70121-1483Arsenic TrioxideArsenic Trioxide
    70860-217Arsenic TrioxideArsenic Trioxide
    0220-0522Arsenicum albumARSENIC TRIOXIDE
    0220-0525Arsenicum albumARSENIC TRIOXIDE
    0220-0526Arsenicum albumARSENIC TRIOXIDE
    0220-0527Arsenicum albumARSENIC TRIOXIDE
    0220-0528Arsenicum albumARSENIC TRIOXIDE
    0220-0529Arsenicum albumARSENIC TRIOXIDE
    0220-0530Arsenicum albumARSENIC TRIOXIDE
    0220-0549Arsenicum albumARSENIC TRIOXIDE
    0220-0550Arsenicum albumARSENIC TRIOXIDE
    0220-0553Arsenicum albumARSENIC TRIOXIDE
    0220-0554Arsenicum albumARSENIC TRIOXIDE
    0220-0557Arsenicum albumARSENIC TRIOXIDE
    10191-1989ARSENICUM ALBUMARSENIC TRIOXIDE
    43406-0318Arsenicum Album 200CArsenic Trioxide
    43406-0168Arsenicum Album 30CArsenic Trioxide

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