NDC 68083-106

Midazolam hydrochloride

Midazolam Hydrochloride

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

Product ID68083-106_1519c9b0-03e1-4e2f-9cb9-a4d693e92c69
NDC68083-106
Product TypeHuman Prescription Drug
Proprietary NameMidazolam hydrochloride
Generic NameMidazolam Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2012-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA090696
Labeler NameGland Pharma Limited
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-106-01

10 VIAL, SINGLE-DOSE in 1 CARTON (68083-106-01) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2012-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-106-01 [68083010601]

Midazolam hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090696
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-06-01

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:23f4df96-1151-4815-8f01-4d79e5aa2145
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1666798
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]
    • 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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