Mannitol
Mannitol Injection, USP
Approved
Approval ID
c395e13d-6ea1-4104-8b37-669cfb982f04
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 16, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MANNITOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-024
Application NumberANDA080677
Product Classification
M
Marketing Category
C73584
G
Generic Name
MANNITOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 16, 2023
FDA Product Classification
INGREDIENTS (1)
MANNITOLActive
Quantity: 250 mg in 1 mL
Code: 3OWL53L36A
Classification: ACTIB