NDC 0409-2596

Midazolam Hydrochloride

Midazolam Hydrochloride

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

Product ID0409-2596_19d3364a-a2af-484e-ab64-d5564f3bf387
NDC0409-2596
Product TypeHuman Prescription Drug
Proprietary NameMidazolam Hydrochloride
Generic NameMidazolam Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2005-11-03
Marketing CategoryANDA / ANDA
Application NumberANDA075293
Labeler NameHospira, Inc.
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesBenzodiazepine [EPC], Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 0409-2596-03

10 VIAL, MULTI-DOSE in 1 CARTON (0409-2596-03) > 5 mL in 1 VIAL, MULTI-DOSE (0409-2596-13)
Marketing Start Date2005-11-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-2596-03 [00409259603]

Midazolam Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075293
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-11-03

NDC 0409-2596-05 [00409259605]

Midazolam Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075293
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-01-12

NDC 0409-2596-52 [00409259652]

Midazolam Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075293
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-02-02
Marketing End Date2020-04-01

NDC 0409-2596-13 [00409259613]

Midazolam Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075293
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-25

NDC 0409-2596-62 [00409259662]

Midazolam Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01
Marketing End Date2020-04-01

NDC 0409-2596-63 [00409259663]

Midazolam Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01
Marketing End Date2020-04-01

NDC 0409-2596-53 [00409259653]

Midazolam Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075293
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-09-30
Marketing End Date2018-06-01

NDC 0409-2596-15 [00409259615]

Midazolam Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075293
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-25

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:affecd4d-1f78-4bbe-5a8d-86849bbdc520
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311702
  • 311700
  • 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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