NDC 0990-7715

Mannitol

Mannitol

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

Product ID0990-7715_54394036-4417-408d-88c8-1b4b2f12ff33
NDC0990-7715
Product TypeHuman Prescription Drug
Proprietary NameMannitol
Generic NameMannitol
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-05-31
Marketing CategoryNDA / NDA
Application NumberNDA019603
Labeler NameICU Medical Inc.
Substance NameMANNITOL
Active Ingredient Strength20 g/100mL
Pharm ClassesIncreased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0990-7715-02

24 POUCH in 1 CASE (0990-7715-02) > 1 BAG in 1 POUCH > 250 mL in 1 BAG (0990-7715-12)
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0990-7715-03 [00990771503]

Mannitol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019603
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-31

NDC 0990-7715-13 [00990771513]

Mannitol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019603
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-31

NDC 0990-7715-02 [00990771502]

Mannitol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019603
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-01

NDC 0990-7715-12 [00990771512]

Mannitol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019603
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
MANNITOL20 g/100mL

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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