NDC 71288-702

Atracurium Besylate

Atracurium Besylate

Atracurium Besylate is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is Atracurium Besylate.

Product ID71288-702_3f332321-c182-43d3-8203-b9a3cc9c3425
NDC71288-702
Product TypeHuman Prescription Drug
Proprietary NameAtracurium Besylate
Generic NameAtracurium Besylate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA091489
Labeler NameMeitheal Pharmaceuticals Inc.
Substance NameATRACURIUM BESYLATE
Active Ingredient Strength10 mg/mL
Pharm ClassesNeuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71288-702-10

10 VIAL, MULTI-DOSE in 1 CARTON (71288-702-10) > 10 mL in 1 VIAL, MULTI-DOSE (71288-702-11)
Marketing Start Date2018-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71288-702-11 [71288070211]

Atracurium Besylate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA091489
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-01

NDC 71288-702-10 [71288070210]

Atracurium Besylate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA091489
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-15

Drug Details

Active Ingredients

IngredientStrength
ATRACURIUM BESYLATE10 mg/mL

OpenFDA Data

SPL SET ID:efe90ee2-fe9e-421f-9e54-2961085d3b12
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 966768
  • 1718913
  • Pharmacological Class

    • Neuromuscular Nondepolarizing Blockade [PE]
    • Nondepolarizing Neuromuscular Blocker [EPC]

    NDC Crossover Matching brand name "Atracurium Besylate" or generic name "Atracurium Besylate"

    NDCBrand NameGeneric Name
    0409-1105Atracurium BesylateATRACURIUM BESYLATE
    0409-1109Atracurium BesylateATRACURIUM BESYLATE
    25021-659Atracurium Besylateatracurium besylate
    25021-672Atracurium Besylateatracurium besylate
    55150-216Atracurium BesylateAtracurium Besylate
    55150-217Atracurium BesylateAtracurium Besylate
    65862-984Atracurium BesylateAtracurium Besylate
    65862-985Atracurium BesylateAtracurium Besylate
    67457-698Atracurium Besylateatracurium besylate
    67457-699Atracurium Besylateatracurium besylate
    71288-701Atracurium BesylateAtracurium Besylate
    71288-702Atracurium BesylateAtracurium Besylate

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