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
NDC Product Code51754-5002
Application NumberANDA211091
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateSeptember 27, 2017
Generic NameSODIUM BICARBONATE
INGREDIENTS (2)
SODIUM BICARBONATEActive
Quantity: 75 mg in 1 mL
Code: 8MDF5V39QO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATE
PRODUCT DETAILS
NDC Product Code51754-5012
Application NumberANDA211091
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateSeptember 27, 2017
Generic NameSODIUM BICARBONATE
INGREDIENTS (2)
SODIUM BICARBONATEActive
Quantity: 42 mg in 1 mL
Code: 8MDF5V39QO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATE
PRODUCT DETAILS
NDC Product Code51754-5001
Application NumberANDA211091
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateSeptember 27, 2017
Generic NameSODIUM BICARBONATE
INGREDIENTS (2)
SODIUM BICARBONATEActive
Quantity: 84 mg in 1 mL
Code: 8MDF5V39QO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATE
PRODUCT DETAILS
NDC Product Code51754-5011
Application NumberANDA211091
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateSeptember 27, 2017
Generic NameSODIUM BICARBONATE
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEActive
Quantity: 84 mg in 1 mL
Code: 8MDF5V39QO
Classification: ACTIB