NDC 52584-589

MIDAZOLAM

Midazolam Hydrochloride

MIDAZOLAM is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc.. The primary component is Midazolam Hydrochloride.

Product ID52584-589_7132f8d2-7ba9-4297-abb6-e795bde74aff
NDC52584-589
Product TypeHuman Prescription Drug
Proprietary NameMIDAZOLAM
Generic NameMidazolam Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-12-24
Marketing CategoryANDA / ANDA
Application NumberANDA090850
Labeler NameGeneral Injectables & Vaccines, Inc.
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-589-22

1 VIAL, MULTI-DOSE in 1 BAG (52584-589-22) > 10 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2018-12-24
Marketing End Date2023-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-589-22 [52584058922]

MIDAZOLAM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090850
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-24

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:dcf771b5-f575-4ab7-b17c-7032e260021f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311702
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

    NDC Crossover Matching brand name "MIDAZOLAM" or generic name "Midazolam Hydrochloride"

    NDCBrand NameGeneric Name
    0404-9912MidazolamMidazolam
    0404-9913MidazolamMidazolam
    0404-9914MIDAZOLAMmidazoalm
    0404-9915MidazolamMidazolam
    70860-601MidazolamMidazolam
    70860-600MidazolamMidazolam
    76045-003MidazolamMidazolam
    76045-001MidazolamMidazolam
    76045-002MidazolamMidazolam
    0641-6057MidazolamMidazolam
    0641-6056MidazolamMidazolam
    0641-6059MidazolamMidazolam
    0641-6061MidazolamMidazolam
    0641-6063MidazolamMidazolam
    0641-6060MidazolamMidazolam
    0641-6210MidazolamMidazolam
    0641-6211MidazolamMidazolam
    0641-6190MidazolamMidazolam
    0641-6209MidazolamMidazolam
    17478-523MidazolamMidazolam
    17478-524MidazolamMidazolam
    47781-589MidazolamMidazolam
    47781-588MidazolamMidazolam
    50090-0683MidazolamMidazolam
    50090-0738MidazolamMidazolam
    50090-3312MidazolamMidazolam
    50090-3435MidazolamMidazolam
    51662-1324MIDAZOLAMMIDAZOLAM
    51662-1236MIDAZOLAMMIDAZOLAM
    51662-1237MIDAZOLAMMIDAZOLAM
    52584-596MidazolamMidazolam
    52584-055MidazolamMidazolam
    52584-056MidazolamMidazolam
    52584-059MidazolamMidazolam
    52584-589MIDAZOLAMMIDAZOLAM
    55154-2889MidazolamMidazolam
    63323-411MidazolamMidazolam
    63323-412MidazolamMidazolam
    65293-412MidazolamMidazolam
    65293-414MidazolamMidazolam
    65293-416MidazolamMidazolam
    65293-415MidazolamMidazolam
    65293-411MidazolamMidazolam
    65293-413MidazolamMidazolam
    65293-417MidazolamMidazolam
    52584-081MidazolamMidazolam
    0054-3566Midazolam HydrochlorideMidazolam Hydrochloride
    0404-9916Midazolam HydrochlorideMidazolam Hydrochloride
    0409-2305MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDE
    0409-2306Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDE

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