Sodium Bicarbonate (Page 3 of 3)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-4.2% Vial Label

NDC 51754-5012-1

Rx Only

4.2% Sodium Bicarbonate Injection, USP

5 mEq/10 mL

(0.5 mEq/mL)

For Intravenous Use Only

10 mL Single Dose Vial

4.2% vial label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL4.2% Vial Carton Label

NDC 51754-5012-4

Rx Only

4.2% Sodium Bicarbonate Injection, USP

5 mEq/10 mL

(0.5 mEq/mL)

For Intravenous Use Only

Discard Unused Portion

20 x 10 mL Single Dose Vials

4.2% vial carton label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-7.5% Vial Label

NDC 51754-5002-1

Rx Only

7.5% Sodium Bicarbonate Injection, USP

44.6 mEq/50 mL

(0.9 mEq/mL)

For Intravenous Use Only

50 mL Single Dose Vial

7.5% vial label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-7.5% Vial Carton Label

NDC 51754-5002-5

Rx Only

7.5% Sodium Bicarbonate Injection, USP

44.6 mEq/50 mL

(0.9 mEq/mL)

For Intravenous Use Only. Discard Unused Portion.

20 x 50 mL Single Dose Vials

7.5 carton
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-8.4% Vial Label

NDC 51754-5001-5

Rx Only

8.4% Sodium Bicarbonate Injection, USP

50 mEq/50 mL

(1 mEq/mL)

For Intravenous Use Only. Discard Unused Portion.

50 mL Single Dose Vial

8.4% vial label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-8.4% Vial Carton Label

NDC 51754-5001-5

Rx Only

8.4% Sodium Bicarbonate Injection, USP

50 mEq/50 mL

(1 mEq/mL)

For Intravenous Use Only

20 x 50 mL Single Dose Vials

8.4 carton
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-8.4% Vial Carton Label

NDC 51754-5001-4

Rx Only

8.4% Sodium Bicarbonate Injection, USP

50 mEq/50 mL

(1 mEq/mL)

For Intravenous Use Only

25 x 50 mL Single Dose Vials

50 mL Vial, 25 ct. Carton
(click image for full-size original)
SODIUM BICARBONATE
sodium bicarbonate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-5001
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 84 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51754-5001-5 20 VIAL in 1 CARTON contains a VIAL
1 50 mL in 1 VIAL This package is contained within the CARTON (51754-5001-5)
2 NDC:51754-5001-4 25 VIAL in 1 CARTON contains a VIAL
2 50 mL in 1 VIAL This package is contained within the CARTON (51754-5001-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211091 08/01/2019
SODIUM BICARBONATE
sodium bicarbonate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-5011
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 84 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51754-5011-4 25 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (51754-5011-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211091 09/01/2020
SODIUM BICARBONATE
sodium bicarbonate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-5002
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51754-5002-5 20 VIAL in 1 CARTON contains a VIAL
1 50 mL in 1 VIAL This package is contained within the CARTON (51754-5002-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211091 09/01/2020
SODIUM BICARBONATE
sodium bicarbonate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-5012
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 42 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51754-5012-4 25 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (51754-5012-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211091 09/27/2018
Labeler — Exela Pharma Sciences, LLC (831274399)
Establishment
Name Address ID/FEI Operations
Exela Pharma Sciences, LLC 831274399 MANUFACTURE (51754-5001), MANUFACTURE (51754-5011), MANUFACTURE (51754-5002), MANUFACTURE (51754-5012), PACK (51754-5001), PACK (51754-5011), PACK (51754-5002), PACK (51754-5012), ANALYSIS (51754-5001), ANALYSIS (51754-5011), ANALYSIS (51754-5002), ANALYSIS (51754-5012)

Revised: 09/2017 Exela Pharma Sciences, LLC

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