NDC Code(s) : 0548-1190-00, 0548-2190-00, 0548-3390-00
Packager : Amphastar Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0548-1190
Route of Administration PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride(UNII: V13007Z41A)
(Lidocaine - UNII:98PI200987) 		Lidocaine Hydrochloride20 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0548-1190-0025 in 1 BOX
15 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083173 09/17/1975
Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0548-2190
Route of Administration PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride(UNII: V13007Z41A)
(Lidocaine - UNII:98PI200987) 		Lidocaine Hydrochloride20 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0548-2190-0025 in 1 BOX
15 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083173 12/01/1992
Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0548-3390
Route of Administration PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride(UNII: V13007Z41A)
(Lidocaine - UNII:98PI200987) 		Lidocaine Hydrochloride20 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0548-3390-0010 in 1 PACKAGE
15 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083173 06/01/2001

PRINCIPAL DISPLAY PANEL

NDC 0548-1190-00
STOCK NO. 1190

Rx Only

MIN-I-JET®
Prefilled Syringe

LIDOCAINE HCl
INJ., USP, 2%
(20 mg/mL)

100 mg
per
5 mL

INTRAVENOUS INJECTION
FOR VENTRICULAR ARRHYTHMIAS MIN-I-JET®   21 G. X 1½" NEEDLE

PRINCIPAL DISPLAY PANEL - MIN-I-JET® Carton

PRINCIPAL DISPLAY PANEL

NDC 0548-2190-00
STOCK NO. 2190

Rx Only

FEATURING STICK-GARD®
18 G. SAFETY INJECTOR

LIDOCAINE HCl
INJ., USP, 2%
(20 mg/mL)

100 mg
per
5 mL

INTRAVENOUS INJECTION
FOR VENTRICULAR ARRHYTHMIAS
STICK-GARD® PREFILLED SYRINGE

PRINCIPAL DISPLAY PANEL - STICK-GARD® Carton

PRINCIPAL DISPLAY PANEL

NDC 0548-3390-00
STOCK NO. 3390

Rx Only

Luer-Lock Prefilled Syringe

LIDOCAINE HCl
INJ., USP, 2%
(20 mg/mL)

100 mg
per
5 mL

INTRAVENOUS INJECTION
FOR VENTRICULAR ARRHYTHMIAS
LUER-JET™ LUER-LOCK PREFILLED SYRINGE

PRINCIPAL DISPLAY PANEL - Luer-Lock Carton