Mannitol
These highlights do not include all the information needed to use MANNITOL INJECTION safely and effectively. See full prescribing information for MANNITOL INJECTION. MANNITOL injection, for intravenous use Initial U.S. Approval: 1964
Approved
Approval ID
8ad3145e-00e7-4412-b9a5-06f00f264f30
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2020
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
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 Code0409-4031
Application NumberNDA016269
Product Classification
M
Marketing Category
C73594
G
Generic Name
MANNITOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 30, 2020
FDA Product Classification
INGREDIENTS (4)
MANNITOLActive
Quantity: 12.5 g in 50 mL
Code: 3OWL53L36A
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT