NDC 17478-524

Midazolam

Midazolam Hydrochloride

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

Product ID17478-524_2087a626-23b5-41eb-82d6-62d3635d5fdc
NDC17478-524
Product TypeHuman Prescription Drug
Proprietary NameMidazolam
Generic NameMidazolam Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2005-05-06
Marketing CategoryANDA / ANDA
Application NumberANDA075494
Labeler NameAkorn, Inc.
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 17478-524-01

10 VIAL in 1 CARTON (17478-524-01) > 1 mL in 1 VIAL
Marketing Start Date2005-05-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-524-05 [17478052405]

Midazolam INJECTION
Marketing CategoryANDA
Application NumberANDA075494
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-06

NDC 17478-524-10 [17478052410]

Midazolam INJECTION
Marketing CategoryANDA
Application NumberANDA075494
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-06

NDC 17478-524-15 [17478052415]

Midazolam INJECTION
Marketing CategoryANDA
Application NumberANDA075494
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-05-06

NDC 17478-524-02 [17478052402]

Midazolam INJECTION
Marketing CategoryANDA
Application NumberANDA075494
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-06

NDC 17478-524-01 [17478052401]

Midazolam INJECTION
Marketing CategoryANDA
Application NumberANDA075494
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-06

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:737361a0-8db1-4d3c-ba5e-44df3f49fa22
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311702
  • 311700
  • UPC Code
  • 0317478524014
  • 0317478523024
  • 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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