NDC 0409-3213

Diazepam

Diazepam

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

Product ID0409-3213_0d1677ed-2a83-4ed4-a455-d652fabf0396
NDC0409-3213
Product TypeHuman Prescription Drug
Proprietary NameDiazepam
Generic NameDiazepam
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2016-02-11
Marketing CategoryANDA / ANDA
Application NumberANDA071583
Labeler NameHospira, Inc.
Substance NameDIAZEPAM
Active Ingredient Strength5 mg/mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0409-3213-12

10 VIAL, MULTI-DOSE in 1 BOX (0409-3213-12) > 10 mL in 1 VIAL, MULTI-DOSE (0409-3213-11)
Marketing Start Date2007-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-3213-10 [00409321310]

Diazepam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-02-11
Marketing End Date2020-04-01

NDC 0409-3213-11 [00409321311]

Diazepam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-10-09

NDC 0409-3213-02 [00409321302]

Diazepam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-24
Marketing End Date2009-06-01

NDC 0409-3213-09 [00409321309]

Diazepam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-02-11
Marketing End Date2020-04-01

NDC 0409-3213-12 [00409321312]

Diazepam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA071583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-10-05

Drug Details

Active Ingredients

IngredientStrength
DIAZEPAM5 mg/mL

OpenFDA Data

SPL SET ID:7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309845
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

    NDC Crossover Matching brand name "Diazepam" or generic name "Diazepam"

    NDCBrand NameGeneric Name
    0054-3188DiazepamDiazepam
    0093-6137DiazepamDiazepam
    0093-6138DiazepamDiazepam
    0093-6139DiazepamDiazepam
    0121-0905DiazepamDiazepam
    0172-3925DiazepamDiazepam
    0172-3926DiazepamDiazepam
    0172-3927DiazepamDiazepam
    68071-4030DiazepamDiazepam
    68071-3330DiazepamDiazepam
    68071-3270DiazepamDiazepam
    68071-4181DiazepamDiazepam
    68071-4770DiazepamDiazepam
    68071-4829DiazepamDiazepam
    68094-750DiazepamDiazepam
    68682-652DiazepamDiazepam
    68682-650DiazepamDiazepam
    68682-655DiazepamDiazepam
    68788-6942DiazepamDiazepam
    68788-9207DiazepamDiazepam
    68788-6851DiazepamDiazepam
    68788-9937DiazepamDiazepam
    68788-9208DiazepamDiazepam
    68788-9936DiazepamDiazepam
    0527-1768DiazepamDiazepam
    0527-1767DiazepamDiazepam
    69339-136DiazepamDiazepam
    70518-0162DiazepamDiazepam
    70518-0014DiazepamDiazepam
    70518-1713DiazepamDiazepam
    70518-1270DiazepamDiazepam
    70518-1856DiazepamDiazepam
    0603-3215DiazepamDiazepam
    71335-0142DiazepamDiazepam
    71335-0444DiazepamDiazepam
    71335-0495DiazepamDiazepam
    71335-0616DiazepamDiazepam
    0615-7800DiazepamDiazepam
    0615-8049DiazepamDiazepam
    0904-5880DiazepamDiazepam
    10544-161DiazepamDiazepam
    11704-600DiazepamDiazepam
    12634-698DIAZEPAMDIAZEPAM
    12634-529DIAZEPAMDIAZEPAM
    17856-3188DiazepamDiazepam
    21695-265DiazepamDiazepam
    21695-264DiazepamDiazepam
    21695-889DiazepamDiazepam
    21695-263DiazepamDiazepam
    33261-034DiazepamDiazepam

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.