NDC 52584-308

Midazolam Hydrochloride

Midazolam Hydrochloride

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

Product ID52584-308_125d0136-c9bf-4959-83b8-0ab56e619b0f
NDC52584-308
Product TypeHuman Prescription Drug
Proprietary NameMidazolam Hydrochloride
Generic NameMidazolam Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2010-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA075857
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-308-01

1 VIAL, SINGLE-DOSE in 1 BAG (52584-308-01) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2010-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-308-02 [52584030802]

Midazolam Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075857
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-01

NDC 52584-308-01 [52584030801]

Midazolam Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075857
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-01

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:d6de628c-bbe5-437e-9338-6f54cd661be1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1666823
  • 1666814
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

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

    NDCBrand NameGeneric Name
    0054-3566Midazolam HydrochlorideMidazolam Hydrochloride
    0404-9916Midazolam HydrochlorideMidazolam Hydrochloride
    0409-2305MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDE
    0409-2306Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDE
    0409-2307Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDE
    0409-2308MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDE
    0409-2587Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDE
    0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDE
    68083-106Midazolam hydrochlorideMidazolam hydrochloride
    68083-108Midazolam HydrochlorideMidazolam Hydrochloride
    68094-762Midazolam HydrochlorideMidazolam Hydrochloride
    68094-764Midazolam HydrochlorideMidazolam Hydrochloride
    68258-8981Midazolam HydrochlorideMidazolam Hydrochloride
    68258-8973Midazolam HydrochlorideMidazolam Hydrochloride
    0574-0150Midazolam HydrochlorideMidazolam Hydrochloride
    17856-0205Midazolam HydrochlorideMidazolam Hydrochloride
    17856-0146Midazolam HydrochlorideMidazolam Hydrochloride
    17856-3566Midazolam HydrochlorideMidazolam Hydrochloride
    23155-600Midazolam hydrochlorideMidazolam hydrochloride
    23155-601Midazolam hydrochlorideMidazolam hydrochloride
    52584-308Midazolam HydrochlorideMidazolam Hydrochloride
    55154-7831MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDE
    55154-4743Midazolam HydrochlorideMidazolam Hydrochloride
    55648-762Midazolam hydrochlorideMidazolam hydrochloride
    55648-764Midazolam hydrochlorideMidazolam hydrochloride
    55648-765Midazolam hydrochlorideMidazolam hydrochloride
    55648-763Midazolam hydrochlorideMidazolam hydrochloride
    63304-205Midazolam HydrochlorideMidazolam Hydrochloride
    64679-763Midazolam hydrochlorideMidazolam hydrochloride
    64679-764Midazolam hydrochlorideMidazolam hydrochloride
    64679-765Midazolam hydrochlorideMidazolam hydrochloride
    64679-762Midazolam hydrochlorideMidazolam hydrochloride

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