NDC Code(s) : 0409-1273-03, 0409-1273-32
Packager : Hospira, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DiazepamDIAZEPAM INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1273
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIAZEPAM(UNII: Q3JTX2Q7TU)
(DIAZEPAM - UNII:Q3JTX2Q7TU) 		DIAZEPAM5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ALCOHOL(UNII: 3K9958V90M)
SODIUM BENZOATE(UNII: OJ245FE5EU)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BENZOIC ACID(UNII: 8SKN0B0MIM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1273-3210 in 1 CARTON 23/08/2005
1NDC:0409-1273-032 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 ANDA072079 08/23/2005

LABELER - Hospira, Inc.(141588017)

Establishment
Name Address ID/FEI Business Operations
Hospira, Inc. 030606222 ANALYSIS(0409-1273), MANUFACTURE(0409-1273), PACK(0409-1273), LABEL(0409-1273)

PRINCIPAL DISPLAY PANEL

2 mL Single-dose Carpuject™
Sterile Cartridge Unit with Luer Lock
Rx only
NDC 0409-1273-03

Diazepam Injection, USP
CIV

PAA132815

10 mg/2 mL (5 mg/mL)

For Intramuscular Or Intravenous Use. Protect from light.

Distributed by
Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

LOT #####AA
EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL - 2 mL Cartridge Label

PRINCIPAL DISPLAY PANEL

NDC 0409-1273-32
Contains 10 of NDC 0409-1273-03

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

Needle not included
SLIM-PAK™
Tamper Detection Package

Diazepam
Injection, USP
CIV

10 mg/2 mL
(5 mg/mL)

For Intramuscular Or
Intravenous Use

Carpuject Cartridges are to be
used ONLY with Carpuject Holders.

Hospira

PRINCIPAL DISPLAY PANEL - 2 mL Cartridge Carton