NDC 0409-4031

Mannitol

Mannitol

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

Product ID0409-4031_785b3a4e-c632-48c6-9fc9-b1b4e7d5d885
NDC0409-4031
Product TypeHuman Prescription Drug
Proprietary NameMannitol
Generic NameMannitol
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2004-11-30
Marketing CategoryNDA / NDA
Application NumberNDA016269
Labeler NameHospira, Inc.
Substance NameMANNITOL
Active Ingredient Strength13 g/50mL
Pharm ClassesIncreased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0409-4031-01

25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) > 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16)
Marketing Start Date2004-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-4031-16 [00409403116]

Mannitol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016269
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-11-14

NDC 0409-4031-01 [00409403101]

Mannitol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016269
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-11-30

Drug Details

Active Ingredients

IngredientStrength
MANNITOL12.5 g/50mL

OpenFDA Data

SPL SET ID:8ad3145e-00e7-4412-b9a5-06f00f264f30
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311450
  • Pharmacological Class

    • Increased Diuresis [PE]
    • Osmotic Activity [MoA]
    • Osmotic Diuretic [EPC]

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

    NDCBrand NameGeneric Name
    0264-2303MannitolMannitol
    0264-7578MannitolMANNITOL
    0404-9905MannitolMannitol
    0409-4031MannitolMANNITOL
    0409-7715MannitolMANNITOL
    0990-7715MannitolMANNITOL
    51662-1468MANNITOLMANNITOL
    52584-031MannitolMannitol
    63323-024MannitolMANNITOL
    67850-552Aridol Bronchial Challenge Test Kitmannitol
    10122-212Bronchitolmannitol
    62171-100GD11 Rx SCM C5MANNITOL
    0338-0351OsmitrolMannitol
    0338-0353OsmitrolMannitol
    0338-0355OsmitrolMannitol
    0338-0357OsmitrolMannitol

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