NDC 0338-0351

Osmitrol

Mannitol

Osmitrol is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Mannitol.

Product ID0338-0351_565121af-2260-4901-a860-62ab0bbeba21
NDC0338-0351
Product TypeHuman Prescription Drug
Proprietary NameOsmitrol
Generic NameMannitol
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1964-06-08
Marketing CategoryNDA / NDA
Application NumberNDA013684
Labeler NameBaxter Healthcare Corporation
Substance NameMANNITOL
Active Ingredient Strength5 g/100mL
Pharm ClassesIncreased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0338-0351-04

1000 mL in 1 BAG (0338-0351-04)
Marketing Start Date1964-06-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0338-0351-04 [00338035104]

Osmitrol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA013684
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1964-06-08

Drug Details

Active Ingredients

IngredientStrength
MANNITOL5 g/100mL

OpenFDA Data

SPL SET ID:0d914965-7001-45cb-ba51-d7c5964b05bc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1791409
  • 1791408
  • 1791395
  • 1791403
  • 1791404
  • 311448
  • 206536
  • 206537
  • 206535
  • 311452
  • Pharmacological Class

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

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

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

    Trademark Results [Osmitrol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OSMITROL
    OSMITROL
    72151100 0751544 Live/Registered
    Travenol Laboratories, Inc.
    1962-08-13

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