NDC 55648-765

Midazolam hydrochloride

Midazolam Hydrochloride

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

Product ID55648-765_cc33c428-6db9-428c-8f4d-f575f27b60b8
NDC55648-765
Product TypeHuman Prescription Drug
Proprietary NameMidazolam hydrochloride
Generic NameMidazolam Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2008-11-10
Marketing CategoryANDA / ANDA
Application NumberANDA078511
Labeler NameWockhardt Limited
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55648-765-03

25 VIAL in 1 CARTON (55648-765-03) > 1 mL in 1 VIAL (55648-765-05)
Marketing Start Date2008-11-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-765-02 [55648076502]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078511
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-10
Inactivation Date2020-01-31

NDC 55648-765-04 [55648076504]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078511
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-10
Inactivation Date2020-01-31

NDC 55648-765-01 [55648076501]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078511
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-10
Inactivation Date2020-01-31

NDC 55648-765-06 [55648076506]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078511
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-10

NDC 55648-765-03 [55648076503]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078511
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-10
Inactivation Date2020-01-31

NDC 55648-765-05 [55648076505]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078511
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-10

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:c94e8384-28b1-4668-95fe-3202497490ae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1666800
  • 1666823
  • 1666798
  • 1666814
    • UPC Code
  • 0364679764053
  • 0364679765067

    • 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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