NDC 68094-764

Midazolam Hydrochloride

Midazolam Hydrochloride

Midazolam Hydrochloride is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Precision Dose Inc.. The primary component is Midazolam Hydrochloride.

Product ID68094-764_27c9904b-7fc7-4054-9f1f-dfc2183ef9bc
NDC68094-764
Product TypeHuman Prescription Drug
Proprietary NameMidazolam Hydrochloride
Generic NameMidazolam Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2015-05-26
Marketing CategoryANDA / ANDA
Application NumberANDA075873
Labeler NamePrecision Dose Inc.
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesBenzodiazepine [EPC], Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68094-764-62

3 TRAY in 1 CASE (68094-764-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-764-59)
Marketing Start Date2015-05-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68094-764-59 [68094076459]

Midazolam Hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA075873
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-05-26

NDC 68094-764-62 [68094076462]

Midazolam Hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA075873
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-05-26

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:9a443652-6aff-4e27-83fe-90c65fa0f3c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 422410

    • 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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