NDC 52584-056

Midazolam

Midazolam

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

Product ID52584-056_6986da54-4608-4b18-8319-59962d5ec374
NDC52584-056
Product TypeHuman Prescription Drug
Proprietary NameMidazolam
Generic NameMidazolam
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-01-08
Marketing End Date2022-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA075243
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN

Packaging

NDC 52584-056-01

1 VIAL in 1 BAG (52584-056-01) > 10 mL in 1 VIAL
Marketing Start Date2018-01-08
Marketing End Date2022-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-056-01 [52584005601]

Midazolam INJECTION
Marketing CategoryANDA
Application NumberANDA075243
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-08
Marketing End Date2022-01-31

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:365bd582-21ca-451e-bc8a-f59f29f63ed6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311700
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

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

    NDCBrand NameGeneric Name
    0404-9912MidazolamMidazolam
    0404-9913MidazolamMidazolam
    0404-9914MIDAZOLAMmidazoalm
    0404-9915MidazolamMidazolam
    0641-6056MidazolamMidazolam
    0641-6057MidazolamMidazolam
    0641-6059MidazolamMidazolam
    0641-6060MidazolamMidazolam
    0641-6061MidazolamMidazolam
    0641-6063MidazolamMidazolam
    0641-6190MidazolamMidazolam
    0641-6209MidazolamMidazolam
    0641-6210MidazolamMidazolam
    0641-6211MidazolamMidazolam
    17478-523MidazolamMidazolam Hydrochloride
    17478-524MidazolamMidazolam Hydrochloride
    47781-588Midazolammidazolam hydrochloride
    47781-589Midazolammidazolam hydrochloride
    50090-0683MidazolamMidazolam
    50090-0738MidazolamMidazolam
    50090-3312Midazolammidazolam hydrochloride
    50090-3435Midazolammidazolam hydrochloride
    51662-1236MIDAZOLAMMIDAZOLAM
    51662-1237MIDAZOLAMMIDAZOLAM
    70860-601MidazolamMidazolam
    70860-600MidazolamMidazolam
    76045-003MidazolamMidazolam
    76045-001MidazolamMidazolam
    76045-002MidazolamMidazolam
    51662-1324MIDAZOLAMMIDAZOLAM
    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
    50474-500Nayzilammidazolam

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