NDC 55648-763

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 ID55648-763_78b2a31c-22dd-42f7-8085-c32010d52256
NDC55648-763
Product TypeHuman Prescription Drug
Proprietary NameMidazolam hydrochloride
Generic NameMidazolam Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2008-05-30
Marketing CategoryANDA / ANDA
Application NumberANDA078141
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 55648-763-06

25 VIAL in 1 CARTON (55648-763-06) > 2 mL in 1 VIAL (55648-763-10)
Marketing Start Date2008-05-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-763-12 [55648076312]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30

NDC 55648-763-07 [55648076307]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30
Inactivation Date2020-01-31

NDC 55648-763-11 [55648076311]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30

NDC 55648-763-05 [55648076305]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30
Inactivation Date2020-01-31

NDC 55648-763-09 [55648076309]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30

NDC 55648-763-01 [55648076301]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30
Inactivation Date2020-01-31

NDC 55648-763-10 [55648076310]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30

NDC 55648-763-02 [55648076302]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30
Inactivation Date2020-01-31

NDC 55648-763-04 [55648076304]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30
Inactivation Date2020-01-31

NDC 55648-763-03 [55648076303]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30
Inactivation Date2020-01-31

NDC 55648-763-06 [55648076306]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30
Inactivation Date2020-01-31

NDC 55648-763-08 [55648076308]

Midazolam hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA078141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:19fbdc82-a727-4345-b67e-d0fd620defca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311702
  • 311700
  • UPC Code
  • 0364679763124
  • 0364679762073
  • 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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