Lidocaine Hydrochloride (Page 6 of 6)

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LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9595
Route of Administration EPIDURAL, INFILTRATION, INTRACAUDAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9595-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0143-9595-01)
1 NDC:0143-9595-01 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0143-9595-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084625 06/16/1975
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9594
Route of Administration EPIDURAL, INFILTRATION, INTRACAUDAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 6 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9594-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0143-9594-01)
1 NDC:0143-9594-01 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0143-9594-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084625 06/16/1975
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 03/2020 Hikma Pharmaceuticals USA Inc.

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