NDC 47781-616

Rocuronium Bromide

Rocuronium Bromide

Rocuronium Bromide is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Alvogen Inc.. The primary component is Rocuronium Bromide.

Product ID47781-616_18726b1b-31cf-833e-2b2a-728865372501
NDC47781-616
Product TypeHuman Prescription Drug
Proprietary NameRocuronium Bromide
Generic NameRocuronium Bromide
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-04-27
Marketing CategoryANDA / ANDA
Application NumberANDA205656
Labeler NameAlvogen Inc.
Substance NameROCURONIUM BROMIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesNeuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47781-616-17

10 VIAL, MULTI-DOSE in 1 CARTON (47781-616-17) > 5 mL in 1 VIAL, MULTI-DOSE (47781-616-20)
Marketing Start Date2018-04-27
Marketing End Date2021-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47781-616-20 [47781061620]

Rocuronium Bromide INJECTION
Marketing CategoryANDA
Application NumberANDA205656
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-04-27

NDC 47781-616-17 [47781061617]

Rocuronium Bromide INJECTION
Marketing CategoryANDA
Application NumberANDA205656
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-04-27

Drug Details

Active Ingredients

IngredientStrength
ROCURONIUM BROMIDE10 mg/mL

OpenFDA Data

SPL SET ID:b31384c3-de18-f7da-3a7f-51bd7dfd4e92
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1234995
  • UPC Code
  • 0347781617912
  • 0347781616175
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Rocuronium Bromide" or generic name "Rocuronium Bromide"

    NDCBrand NameGeneric Name
    0143-9250Rocuronium BromideRocuronium Bromide
    0143-9251Rocuronium BromideRocuronium Bromide
    0409-9558ROCURONIUM BROMIDEROCURONIUM BROMIDE
    0703-2394Rocuronium BromideRocuronium Bromide
    0703-2395Rocuronium BromideRocuronium Bromide
    0781-3220Rocuronium BromideRocuronium Bromide
    25021-662rocuronium bromiderocuronium bromide
    39822-4200rocuronium bromiderocuronium bromide
    43066-007Rocuronium BromideRocuronium Bromide
    43066-013Rocuronium BromideRocuronium Bromide
    43547-530ROCURONIUM BROMIDErocuronium bromide
    43547-531ROCURONIUM BROMIDErocuronium bromide
    47781-616Rocuronium Bromiderocuronium bromide
    47781-617Rocuronium Bromiderocuronium bromide
    51662-1354ROCURONIUM BROMIDEROCURONIUM BROMIDE
    51662-1355ROCURONIUM BROMIDEROCURONIUM BROMIDE
    68083-364Rocuronium BromideRocuronium Bromide
    68083-365Rocuronium BromideRocuronium Bromide
    70860-651Rocuronium BromideRocuronium Bromide
    71872-7036rocuronium bromiderocuronium bromide
    55150-225Rocuronium BromideRocuronium Bromide
    55150-226Rocuronium BromideRocuronium Bromide
    59651-115Rocuronium BromideRocuronium Bromide
    59651-116Rocuronium BromideRocuronium Bromide
    67457-228Rocuronium BromideRocuronium Bromide
    67457-573Rocuronium BromideRocuronium Bromide
    67457-574Rocuronium BromideRocuronium Bromide
    55579-400Rocuronium BromideRocuronium Bromide
    71479-004Rocuronium bromideRocuronium bromide

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