NDC 0409-2308

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 ID0409-2308_030ed4cc-b5a6-4338-852d-f9ab8c23b17c
NDC0409-2308
Product TypeHuman Prescription Drug
Proprietary NameMIDAZOLAM HYDROCHLORIDE
Generic NameMidazolam Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2005-11-21
Marketing CategoryANDA / ANDA
Application NumberANDA075857
Labeler NameHospira, Inc.
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0409-2308-49

10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2308-49) > 1 mL in 1 VIAL, SINGLE-DOSE (0409-2308-69)
Marketing Start Date2005-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-2308-01 [00409230801]

MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-06-14

NDC 0409-2308-22 [00409230822]

MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-25

NDC 0409-2308-50 [00409230850]

MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-11-21

NDC 0409-2308-69 [00409230869]

MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-25

NDC 0409-2308-02 [00409230802]

MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-10-04

NDC 0409-2308-70 [00409230870]

MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-25

NDC 0409-2308-49 [00409230849]

MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-12-28

NDC 0409-2308-21 [00409230821]

MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-25

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:b95415fa-17c2-42ab-a6b0-e628d01c94ed
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1666800
  • 1666823
  • 1666798
  • 1666814

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.