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

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

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

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

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

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

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

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