NDC 63323-412

Midazolam

Midazolam Hydrochloride

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

Product ID63323-412_09daf48f-1d44-4b7b-bb53-bd5635b93ca6
NDC63323-412
Product TypeHuman Prescription Drug
Proprietary NameMidazolam
Generic NameMidazolam Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2017-03-28
Marketing CategoryANDA / ANDA
Application NumberANDA208878
Labeler NameFresenius Kabi USA, LLC
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 63323-412-02

10 VIAL in 1 TRAY (63323-412-02) > 2 mL in 1 VIAL (63323-412-03)
Marketing Start Date2000-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-412-03 [63323041203]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-22

NDC 63323-412-10 [63323041210]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-10

NDC 63323-412-02 [63323041202]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-10

NDC 63323-412-00 [63323041200]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA208878
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-28

NDC 63323-412-05 [63323041205]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-10

NDC 63323-412-13 [63323041213]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-22

NDC 63323-412-06 [63323041206]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-22

NDC 63323-412-25 [63323041225]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-10

NDC 63323-412-18 [63323041218]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-22

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:09daf48f-1d44-4b7b-bb53-bd5635b93ca6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311702

    • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

    Medicade Reported Pricing

    63323041210 MIDAZOLAM HCL 5 MG/ML VIAL

    Pricing Unit: ML | Drug Type:

    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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