LIDO-MP40 (Page 11 of 11)

Principal Display Panel – Ampule Label

NDC 0409-4713-32

2 mL Single-dose Rx only

Preservative-Free

1% LIDOCAINE HCl
Injection, USP
10 mg/mL

HOSPIRA, INC.
LAKE FOREST, IL 60045 USA

RL-1045 (11/04)

Principal Display Panel – Ampule Label
(click image for full-size original)

Principal Display Panel – Kit Label

NDC 69101-713-01 Rx-Only

LIDO-MP40 KIT

Kit Contains:
1 Methylprednisolone Acetate Injectable Suspension, USP 40 mg/ mL (1mL)
2 Lidocaine HCl Injection, USP 1% (2 mL)
6 Isopropyl Alcohol 70% Prep Pads
1 Pair Nitrile Powder Free Sterile Gloves (Size: Large)
1 Adhesive Bandage
Sterile 4×4 Gauze

Distributed by:
Burke Therapeutics Hot Springs, AR 71913

Principal Display Panel – Kit Label
(click image for full-size original)
Principal Display Panel – Kit Label
(click image for full-size original)
LIDO-MP40 methylprednisolone, lidocaine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69101-713
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69101-713-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-DOSE 1 mL
Part 2 2 AMPULE 4 mL
Part 1 of 2
METHYLPREDNISOLONE ACETATE methylprednisolone acetate injection, suspension
Product Information
Item Code (Source) NDC:0703-0031
Route of Administration INTRAMUSCULAR, SOFT TISSUE, INTRA-ARTICULAR, INTRALESIONAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE ACETATE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
MIRIPIRIUM CHLORIDE
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0703-0031-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0703-0031-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040557 03/08/2005
Part 2 of 2
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection, solution
Product Information
Item Code (Source) NDC:0409-4713
Route of Administration INFILTRATION 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
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-4713-32 2 mL in 1 AMPULE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080408 09/28/1972
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA040557 06/18/2015
Labeler — Burke Therapeutics, LLC (079259903)

Revised: 06/2015 Burke Therapeutics, LLC

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