NDC 65293-417

Midazolam

Midazolam Hydrochloride

Midazolam is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by The Medicines Company. The primary component is Midazolam Hydrochloride.

Product ID65293-417_7ad32932-64e4-4cc5-b749-bc1a737df391
NDC65293-417
Product TypeHuman Prescription Drug
Proprietary NameMidazolam
Generic NameMidazolam Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2000-07-14
Marketing CategoryANDA / ANDA
Application NumberANDA075154
Labeler NameThe Medicines Company
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65293-417-25

25 VIAL in 1 TRAY (65293-417-25) > 1 mL in 1 VIAL (65293-417-01)
Marketing Start Date2000-07-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65293-417-01 [65293041701]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-14
Marketing End Date2016-03-31

NDC 65293-417-25 [65293041725]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-27
Marketing End Date2016-03-31

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:ccf2b7bd-b282-420e-b929-bf82384ab4a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311702
  • 311700
  • 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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