Prescription Drug Information: Point Of Care L5 (Page 7 of 7)

HOW SUPPLIED

Lidocaine Hydrochloride Injection, USP is supplied as follows:

Single-dose products are preservative-free.

NDC 55150-0159-74 Injection 5mL

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS.

Revised: February, 2010

Printed in USA EN-2421

Hospira, Inc., Lake Forest, IL 60045 USA

DEPO-MEDROL Principal Display Panel – Vial Label

NDC 0009-3073-01

1 mL Single-Dose Vial


Depo-Medrol®

(methylprednisolone


acetate injectable


suspension, USP)

40 mg/mL

Rx only

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

LIDOCAINE INJECTION

PDP
(click image for full-size original)

NDC 70859-038-01

pdp
(click image for full-size original)

POINT OF CARE L5
depo-medrol, lidocaine hci, isopropyl alcohol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70859-038
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70859-038-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 VIAL, SINGLE-DOSE 2 mL
Part 2 2 AMPULE 10 mL
Part 3 3 POUCH 15 mL
Part 1 of 3
DEPO-MEDROL
methylprednisolone acetate injection, suspension
Product Information
Item Code (Source) NDC:0009-3073
Route of Administration INTRAMUSCULAR, INTRA-ARTICULAR, INTRALESIONAL, SOFT TISSUE 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 29 mg in 1 mL
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0009-3073-01 1 VIAL, SINGLE-DOSE in 1 PACKAGE contains a VIAL, SINGLE-DOSE
1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the PACKAGE (0009-3073-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011757 05/28/1959
Part 2 of 3
LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride injection, solution
Product Information
Item Code (Source) NDC:55150-159
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 7 mg in 1 mL
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 5 mL in 1 AMPULE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203040 03/14/2010
Part 3 of 3
ISOPROPYL ALCOHOL
isopropyl alcohol dressing
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 5 mL in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/01/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011757 05/28/1959
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 manufacture (70859-038)

Revised: 05/2021 NuCare Pharmaceuticals,Inc.

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