Lidocaine (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NDC 0143-9578 -01 Rx only
Lidocaine
HCl Injection, USP
1%
300 mg/30 mL
(10 mg/mL)
For Infiltration and Nerve Block
Not For Epidural or Caudal Use 30 mL Multiple Dose Vial

1% 30 mL February 2015
(click image for full-size original)

NDC 0143-9578 -10 Rx only
Lidocaine
HCl Injection, USP
1%
300 mg/30 mL
(10 mg/mL)
For Infiltration and Nerve Block
Not For Epidural or Caudal Use
Methylparaben as Preservative10 x 30 mL Multiple Dose Vials

1% 30 mL x 10 February 2015
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-9577 -01 Rx only
Lidocaine
HCl Injection, USP
1%
(500 mg/50 mL)
(10 mg/mL)
For Infiltration and Nerve Block
NOT For Epidural or Caudal Use
Methylparaben as Preservative 50 mL Multiple Dose Vial

vial
(click image for full-size original)

NDC 0143-9577 -10 Rx only
Lidocaine
HCl Injection, USP
1%
(500 mg/50 mL)
(10 mg/mL)
For Infiltration and Nerve Block
NOT For Epidural or Caudal Use
Methylparaben as Preservative 10 x 50 mL Multiple Dose Vials

sp
(click image for full-size original)

vialsp

PRINCIPAL DISPLAY PANEL

NDC 0143-9576 -01 Rx only
Lidocaine
HCl Injection, USP
2%
40 mg/2 mL
(20 mg/mL)
For Infiltration and
Nerve Block
Not For Epidural or
Caudal Use 2 mL Multiple Dose Vial

2% 2 mL vial February 2015
(click image for full-size original)

NDC 0143-9576 -25 Rx only
Lidocaine
HCl Injection, USP
2%
40 mg/2mL
(20 mg/mL)
For Infiltration and Nerve Block
Not For Epidural or Caudal Use
Methylparaben as Preservative 25 x 2 mL Multiple Dose Vials

2% 2 mL vial x 25 February 2015
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-9575 -01 Rx only
Lidocaine
HCl Injection, USP
2%
(1,000 mg/50 mL)
(20 mg/mL)
For Infiltration and Nerve Block
NOT For Epidural or Caudal Use
Methylparaben as Preservative 50 mL Multiple Dose Vial

vial
(click image for full-size original)

NDC 0143-9575 -10 Rx only
Lidocaine
HCl Injection, USP
2%
(1,000 mg/50 mL)
(20 mg/mL)
For Infiltration and Nerve Block
NOT For Epidural or Caudal Use
Methylparaben as Preservative 10 x 50 mL Multiple Dose Vials

sp
(click image for full-size original)

SERIALIZATION IMAGE

LAYOUT 1LAYOUT 1
LIDOCAINE lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9579
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7 mg in 1 mL
METHYLPARABEN 1 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9579-25 25 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE (0143-9579-01)
1 NDC:0143-9579-01 2 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (0143-9579-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080407 02/14/1972
LIDOCAINE lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9578
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7 mg in 1 mL
METHYLPARABEN 1 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9578-10 10 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE (0143-9578-01)
1 NDC:0143-9578-01 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (0143-9578-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080407 02/14/1972
LIDOCAINE lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9577
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7 mg in 1 mL
METHYLPARABEN 1 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9577-10 10 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE (0143-9577-01)
1 NDC:0143-9577-01 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (0143-9577-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080407 02/14/1972
LIDOCAINE lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9576
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 6 mg in 1 mL
METHYLPARABEN 1 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9576-25 25 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE (0143-9576-01)
1 NDC:0143-9576-01 2 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (0143-9576-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080407 02/14/1972
LIDOCAINE lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9575
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 6 mg in 1 mL
METHYLPARABEN 1 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9575-10 10 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE (0143-9575-01)
1 NDC:0143-9575-01 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (0143-9575-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080407 02/14/1972
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 03/2020 Hikma Pharmaceuticals USA Inc.

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