NDC 68083-365

Rocuronium Bromide

Rocuronium Bromide

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

Product ID68083-365_0335fa9d-ed70-428c-b6a6-df44f8ba15e8
NDC68083-365
Product TypeHuman Prescription Drug
Proprietary NameRocuronium Bromide
Generic NameRocuronium Bromide
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-05-18
Marketing CategoryANDA / ANDA
Application NumberANDA205656
Labeler NameGland Pharma Limited
Substance NameROCURONIUM BROMIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesNeuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68083-365-10

10 VIAL, MULTI-DOSE in 1 CARTON (68083-365-10) > 10 mL in 1 VIAL, MULTI-DOSE (68083-365-01)
Marketing Start Date2018-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-365-01 [68083036501]

Rocuronium Bromide INJECTION
Marketing CategoryANDA
Application NumberANDA205656
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-18

NDC 68083-365-10 [68083036510]

Rocuronium Bromide INJECTION
Marketing CategoryANDA
Application NumberANDA205656
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-18

Drug Details

Active Ingredients

IngredientStrength
ROCURONIUM BROMIDE10 mg/mL

OpenFDA Data

SPL SET ID:a223a740-dbe8-4d06-8b8b-d9104b694e62
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1234995
  • 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

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