Calcium Gluconate
These highlights do not include all the information needed to use CALCIUM GLUCONATE IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE IN SODIUM CHLORIDE INJECTION. CALCIUM GLUCONATE IN SODIUM CHLORIDE INJECTION, for intravenous use Initial U.S. Approval: 1941
Approved
Approval ID
7f5101e0-abf9-4fcf-8986-c799e3333434
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 25, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcium Gluconate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-162
Application NumberNDA208418
Product Classification
M
Marketing Category
C73594
G
Generic Name
Calcium Gluconate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CALCIUM SACCHARATEInactive
Code: 6AP9J91K4V
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CALCIUM GLUCONATE MONOHYDRATEActive
Quantity: 20 mg in 1 mL
Code: CZN0MI5R31
Classification: ACTIB
Calcium Gluconate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-164
Application NumberNDA208418
Product Classification
M
Marketing Category
C73594
G
Generic Name
Calcium Gluconate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (5)
CALCIUM GLUCONATE MONOHYDRATEActive
Quantity: 20 mg in 1 mL
Code: CZN0MI5R31
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CALCIUM SACCHARATEInactive
Code: 6AP9J91K4V
Classification: IACT