NDC Code(s) : 0409-1920-10, 0409-1941-01
Packager : Hospira, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TalwinPENTAZOCINE LACTATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1920
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENTAZOCINE LACTATE(UNII: 1P2XIB510O)
(PENTAZOCINE - UNII:RP4A60D26L) 		PENTAZOCINE30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETONE SODIUM BISULFITE(UNII: 47VY054OXY)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
METHYLPARABEN(UNII: A2I8C7HI9T)
WATER(UNII: 059QF0KO0R)
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1920-101 in 1 CARTON 30/09/2005
110 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016194 09/30/2005 03/01/2012
TalwinPENTAZOCINE LACTATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1941
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENTAZOCINE LACTATE(UNII: 1P2XIB510O)
(PENTAZOCINE - UNII:RP4A60D26L) 		PENTAZOCINE30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1941-015 in 1 CARTON 18/11/2005
15 in 1 TRAY
11 mL in 1 AMPULE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016194 11/18/2005

PRINCIPAL DISPLAY PANEL

10 mL Multi-Dose Vial

Talwin™
Injection
CIV

Pentazocine
Injection, USP

30 mg
base per mL

Printed in USA
Hospira, Inc., Lake Forest, IL 60045 USA

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

PRINCIPAL DISPLAY PANEL

10 mL
Multi-dose Vial

NDC 0409-1920-10
Rx only

Talwin™
Injection
CIV

Pentazocine
Injection, USP

30 mg
base per mL

Sterile Aqueous Injection

Warning:
Contains Sulfites

Hospira

PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton

PRINCIPAL DISPLAY PANEL

1 mL

NDC 0409-1941-01
Rx only

Talwin™
Injection
Pentazocine
Injection, USP

CIV

30 mg base/mL

Hospira, Inc.,
Lake Forest, IL 60045 USA

Hospira

PRINCIPAL DISPLAY PANEL - 1 mL Ampul Label

PRINCIPAL DISPLAY PANEL

1 mL UNI-AMP™ unit dose pak

Talwin™ Injection

Pentazocine Injection, USP

30 mg base/mL

Hospira

CIV

NDC 0409-1941-01

Hospira, Inc.,
Lake Forest, IL 60045 USA

Rx only

IM-2064

PRINCIPAL DISPLAY PANEL - 1 mL Ampul Tray

PRINCIPAL DISPLAY PANEL

1 mL
25 ampuls UNI-AMP™ unit dose pak

NDC 0409-1941-01
Rx only

Talwin™ Injection
Pentazocine Injection, USP
CIV

30 mg base/mL

Sterile Aqueous Injection

Hospira

PRINCIPAL DISPLAY PANEL - 1 mL Ampul Tray Carton