ReadySharp Lidocaine: Package Insert and Label Information (Page 3 of 3)

HOW SUPPLIED

Lidocaine Hydrochloride Injection, USP is supplied as follows:

Unit of Sale

Concentration

Each

Single-dose

NDC 0409-4278-01

Tray of 25

0.5%

250 mg/50 mL

(5 mg/mL)

NDC 0409-4278-16

Glass Teartop Vial

NDC 0409-4713-02

Carton of 25

1%

50 mg/5 mL

(10 mg/mL)

NDC 0409-4713-12

Glass Ampul

NDC 0409-4713-32

Carton of 50

1%

20 mg/2 mL

(10 mg/mL)

NDC 0409-4713-42

Glass Ampul

NDC 0409-4713-62

Case of 800

1%

20 mg/2 mL

(10 mg/mL)

NDC 0409-4713-72

Glass Ampul

NDC 0409-4713-65

Case of 800

1%

50 mg/5 mL

(10 mg/mL)

NDC 0409-4713-75

Glass Ampul

NDC 0409-4279-02

Carton of 25

1%

300 mg/30 mL

(10 mg/mL)

NDC 0409-4279-16

Glass Teartop Vial

NDC 0409-4270-01

Case of 25

1%

300 mg/30 mL

(10 mg/mL)

NDC 0409-4270-11

Sterile Glass Teartop Vial

NDC 0409-4776-01

Carton of 25

1.5%

300 mg/20 mL

(15 mg/mL)

NDC 0409-4776-10

Glass Ampul

NDC 0409-4056-01

Carton of 5

1.5%

300 mg/20 mL

(15 mg/mL)

NDC 0409-4056-11

Sterile Glass Ampul

NDC 0409-4282-01

Bundle of 25

2%

40 mg/2 mL

(20mg/mL)

NDC 0409-4282-11

Glass Ampul

NDC 0409-4282-02

Carton of 25

2%

200 mg/10 mL

(20 mg/mL)

NDC 0409-4282-12

Glass Ampul

Unit of Sale

Concentration

Each

Multiple-dose:

NDC 0409-4275-01

Tray of 25

0.5%

250 mg/50 mL

(5 mg/mL)

NDC 0409-4275-16

Plastic Fliptop Vial

NDC 0409-4276-01

Tray of 25

1%

200 mg/20 mL

(10 mg/mL)

NDC 0409-4276-16

Plastic Fliptop Vial

NDC 0409-4276-02

Tray of 25

1%

500 mg/50 mL

(10 mg/mL)

NDC 0409-4276-17

Plastic Fliptop Vial

NDC 0409-4277-01

Tray of 25

2%

400 mg/20 mL

(20 mg/mL)

NDC 0409-4277-16

Plastic Fliptop bottle

NDC 0409-4277-02

Tray of 25

2%

1000 mg/50 mL

(20 mg/mL)

NDC 0409-4277-17

Plastic Fliptop Vial

Single-dose products are preservative-free.

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: 1/2015

EN-3679

Hospira, Inc., Lake Forest, IL 60045 USA Hospira logo

ReadyShary Lidocaine

ReadySharp Lidocaine

CONTENTS:

1 Lidocaine Hydrochloride 1%, 2 mL
1 Sterile Alcohol Prep Pad

1 Adhesive Bandage

3 Povidone-Iodine Swabsticks

1 Retractable Syringe w/ Needle 23G x 1

NDC 53225-3600-1

REF

Packaged in the USA for:

Terrain Pharmaceuticals

Reno, NV 89501

877-985-8377

ReadySharp.us

Non-Sterile

Single Use Only

CAUTION: Federal law restricts this device for sale by or on the order of a physician. This package has not been terminally sterilized. Individual items in package can be sterile where indicated by the original manufacturer. Do not sterilize. Store between 68°F – 77°F.

3600
(click image for full-size original)

ReadySharp Lidocaine

CONTENTS:

1 Lidocaine Hydrochloride 1%, 50 mL
1 Sterile Alcohol Prep Pad

1 Adhesive Bandage

3 Povidone-Iodine Swabsticks

1 Retractable Syringe w/ Needle 23G x 1
NDC 53225-3700-1

REF

Packaged in the USA for:

Terrain Pharmaceuticals

Reno, NV 89501

877-985-8377

ReadySharp.us

Non-Sterile

Single Use Only

CAUTION: Federal law restricts this device for sale by or on the order of a physician. This package has not been terminally sterilized. Individual items in package can be sterile where indicated by the original manufacturer. Do not sterilize. Store between 68°F – 77°F.

3700
(click image for full-size original)

ReadySharp Lidocaine

CONTENTS:

1 Lidocaine Hydrochloride 1%, 5 mL
1 Sterile Alcohol Prep Pad

1 Adhesive Bandage

3 Povidone-Iodine Swabsticks

1 Retractable Syringe w/ Needle 23G x 1

NDC 53225-3800-1

REF

Packaged in the USA for:

Terrain Pharmaceuticals

Reno, NV 89501

877-985-8377

ReadySharp.us

Non-Sterile

Single Use Only

CAUTION: Federal law restricts this device for sale by or on the order of a physician. This package has not been terminally sterilized. Individual items in package can be sterile where indicated by the original manufacturer. Do not sterilize. Store between 68°F – 77°F.

3800
(click image for full-size original)
READYSHARP LIDOCAINE
lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53225-3600
Route of Administration INFILTRATION, PERINEURAL, EPIDURAL, 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
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53225-3600-1 2 mL in 1 AMPULE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203082 03/14/2013
READYSHARP LIDOCAINE
lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53225-3800
Route of Administration EPIDURAL, INTRACAUDAL, INFILTRATION, PERINEURAL 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 NDC:53225-3800-1 5 mL in 1 AMPULE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080408 07/08/2005
READYSHARP LIDOCAINE
lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53225-3700
Route of Administration INFILTRATION, PERINEURAL, EPIDURAL, 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
METHYLPARABEN 1 mg in 1 mL
SODIUM CHLORIDE 7 mg in 1 mL
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53225-3700-1 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088299 07/12/2005
Labeler — Terrain Pharmaceuticals (078358750)

Revised: 10/2021 Terrain Pharmaceuticals

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