NDC Code(s) : 63323-323-20, 63323-324-62
Packager : APP Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Penicillin G PotassiumPENICILLIN G POTASSIUM POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-323
Route of Administration INTRAMUSCULAR, INTRAVENOUS, INTRAPLEURAL, INTRATHECAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIN G POTASSIUM(UNII: VL775ZTH4C)
(PENICILLIN G - UNII:Q42T66VG0C) 		PENICILLIN G5000000 [iU]
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-323-2010 in 1 TRAY
11 in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065448 09/01/2009
Penicillin G PotassiumPENICILLIN G POTASSIUM POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-324
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIN G POTASSIUM(UNII: VL775ZTH4C)
(PENICILLIN G - UNII:Q42T66VG0C) 		PENICILLIN G20000000 [iU]
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-324-621 in 1 CARTON
11 in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065448 09/01/2009

PRINCIPAL DISPLAY PANEL

Penicillin G Potassium for Injection, USP 5,000,000 Units per Vial - Label

NDC 63323-323-20 320320

Buffered
PENICILLIN G
POTASSIUM
FOR INJECTION, USP

5,000,000 Units*
per Vial
(5 million units*
per vial)

For IM or IV Use

Rx only

PRINCIPAL DISPLAY PANEL

Penicillin G Potassium for Injection, USP 20,000,000 Units per Vial - Label NDC 63323-324-62 320462

Buffered
PENICILLIN G
POTASSIUM
FOR INJECTION, USP

20,000,000 Units* per Vial
(20 million units* per vial)

FOR INTRAVENOUS
INFUSION ONLY

Rx only