NDC 52584-031

Mannitol

Mannitol

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

Product ID52584-031_23fbdef9-7b67-431e-80e7-0bc781e38975
NDC52584-031
Product TypeHuman Prescription Drug
Proprietary NameMannitol
Generic NameMannitol
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-11-19
Marketing End Date2023-12-01
Marketing CategoryNDA / ANDA
Application NumberNDA016269
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameMANNITOL
Active Ingredient Strength13 g/50mL
Pharm ClassesIncreased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]
NDC Exclude FlagN

Packaging

NDC 52584-031-01

1 VIAL, SINGLE-DOSE in 1 BAG (52584-031-01) > 50 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-11-19
Marketing End Date2023-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-031-01 [52584003101]

Mannitol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016269
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-19

Drug Details

Active Ingredients

IngredientStrength
MANNITOL12.5 g/50mL

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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