Sodium Bicarbonate
Sodium Bicarbonate Injection, USP
Approved
Approval ID
e9698a4f-1a95-4f28-a945-e8009d1d6dd4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2017
Manufacturers
FDA
Exela Pharma Sciences, LLC
DUNS: 831274399
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM BICARBONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-5002
Application NumberANDA211091
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM BICARBONATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 27, 2017
FDA Product Classification
INGREDIENTS (2)
SODIUM BICARBONATEActive
Quantity: 75 mg in 1 mL
Code: 8MDF5V39QO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-5012
Application NumberANDA211091
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM BICARBONATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 27, 2017
FDA Product Classification
INGREDIENTS (2)
SODIUM BICARBONATEActive
Quantity: 42 mg in 1 mL
Code: 8MDF5V39QO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-5001
Application NumberANDA211091
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM BICARBONATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 27, 2017
FDA Product Classification
INGREDIENTS (2)
SODIUM BICARBONATEActive
Quantity: 84 mg in 1 mL
Code: 8MDF5V39QO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-5011
Application NumberANDA211091
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM BICARBONATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 27, 2017
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEActive
Quantity: 84 mg in 1 mL
Code: 8MDF5V39QO
Classification: ACTIB