NDC 70860-600

Midazolam

Midazolam Hydrochloride

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

Product ID70860-600_7127df3c-7f15-4623-95aa-adf0173620ac
NDC70860-600
Product TypeHuman Prescription Drug
Proprietary NameMidazolam
Generic NameMidazolam Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2016-12-14
Marketing CategoryANDA / ANDA
Application NumberANDA090696
Labeler NameAthenex Pharmaceutical Division, LLC.
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength2 mg/2mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70860-600-02

25 VIAL, SINGLE-DOSE in 1 CARTON (70860-600-02) > 2 mL in 1 VIAL, SINGLE-DOSE (70860-600-41)
Marketing Start Date2016-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70860-600-41 [70860060041]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090696
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-12-05

NDC 70860-600-02 [70860060002]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090696
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-14

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE2 mg/2mL

OpenFDA Data

SPL SET ID:401a66d1-9374-40af-acd2-73e573584da2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1666798
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.