NDC Code(s) : 63323-026-05
Packager : APP Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sodium BicarbonateSODIUM BICARBONATE SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-026
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
(BICARBONATE ION - UNII:HN1ZRA3Q20) 		SODIUM BICARBONATE42 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CARBON DIOXIDE(UNII: 142M471B3J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-026-0525 in 1 TRAY
15 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/10/2000

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY - SODIUM BICARBONATE 5 mL Single Dose Vial Label

NDC 63323-026-05

2605

Sodium Bicarbonate

4.2 % (2.5 mEq/5 mL)

Neutralizing Additive Solution

Not for Direct Injection

5 mL Single dose Vial

Rx only

2605-vial