Dextrose Monohydrate
Approved
Approval ID
fcc7ac79-cd70-4f03-a4de-f051f9ca1f7d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2022
Manufacturers
FDA
International Medication Systems, Limited
DUNS: 055750020
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dextrose Monohydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76329-3302
Application NumberANDA203451
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextrose Monohydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 11, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Dextrose monohydrateActive
Quantity: 25 g in 50 mL
Code: LX22YL083G
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT