NDC 68382-997

Arsenic trioxide

Arsenic Trioxide

Arsenic trioxide is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Arsenic Trioxide.

Product ID68382-997_54d06123-60b4-48df-b4d0-4ddfdb0ecdfa
NDC68382-997
Product TypeHuman Prescription Drug
Proprietary NameArsenic trioxide
Generic NameArsenic Trioxide
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-11-14
Marketing CategoryANDA / ANDA
Application NumberANDA206228
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameARSENIC TRIOXIDE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68382-997-10

10 VIAL in 1 CARTON (68382-997-10) > 10 mL in 1 VIAL (68382-997-01)
Marketing Start Date2018-11-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-997-10 [68382099710]

Arsenic trioxide INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206228
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-14

NDC 68382-997-01 [68382099701]

Arsenic trioxide INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206228
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-14

Drug Details

Active Ingredients

IngredientStrength
ARSENIC TRIOXIDE1 mg/mL

OpenFDA Data

SPL SET ID:e9d27f88-de82-4379-b143-4b94b3dd8bbe
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

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