MANNITOL
25% MANNITOL INJECTION, USP 12.5g/50mL (250mg/mL) 50mL VIAL
Approved
Approval ID
999ce711-2d5b-0d7d-e053-2995a90a2689
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2024
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MANNITOL
PRODUCT DETAILS
NDC Product Code51662-1468
Application NumberNDA016269
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJanuary 27, 2024
Generic NameMANNITOL
INGREDIENTS (4)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MANNITOLActive
Quantity: 12.5 g in 50 mL
Code: 3OWL53L36A
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT