NDC Code(s) : 0409-2012-03, 0409-2012-32
Packager : Hospira, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Buprenorphine HydrochlorideBuprenorphine Hydrochloride INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-2012
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1)
(BUPRENORPHINE - UNII:40D3SCR4GZ) 		BUPRENORPHINE0.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DEXTROSE(UNII: 5SL0G7R0OK)50 mg in 1 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-2012-3210 in 1 CARTON 14/06/2005
1NDC:0409-2012-031 mL in 1 CARTRIDGE Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074137 06/14/2005

LABELER - Hospira, Inc.(141588017)

Establishment
Name Address ID/FEI Business Operations
Hospira, Inc. 030606222 ANALYSIS(0409-2012), MANUFACTURE(0409-2012)

PRINCIPAL DISPLAY PANEL

NDC 0409-2012-03

1 mL Single-dose Carpuject™
Sterile Cartridge Unit with Luer Lock
Buprenorphine
Hydrochloride Injection
CIII
Rx only
0.3 mg base/mL
For Intramuscular or Intravenous Use
PROTECT FROM LIGHT

PAA146018

Hospira

LOT #####AA
EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL - 1 mL Cartridge Label

PRINCIPAL DISPLAY PANEL

NDC 0409-2012-32
Contains 10 of NDC 0409-2012-03
Rx only

1 mL Single-dose
10 Carpuject™
Sterile Cartridge Units
with Luer Lock

Needle not included

SLIM-PAK™
Tamper Detection Package

Buprenorphine
Hydrochloride
Injection
CIII

0.3 mg base/mL

For Intramuscular or
Intravenous Use

Carpuject Cartridges are
to be used ONLY with
Carpuject Holders.

Hospira

PRINCIPAL DISPLAY PANEL - 1 mL Cartridge Carton