Levetiracetam (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68083-152-01
Levetiracetam in 0.82% Sodium Chloride Injection (500 mg/100 mL) (5 mg/mL)
Rx OnlyFor Intravenous Infusion Only

levetiracetam-spl-bag-1
(click image for full-size original)


NDC 68083-153-01
Levetiracetam in 0.75% Sodium Chloride Injection (1,000 mg/100 mL) (10 mg/mL)
Rx OnlyFor Intravenous Infusion Only

levetiracetam-spl-bag-2
(click image for full-size original)

NDC 68083-154-01
Levetiracetam in 0.54% Sodium Chloride Injection (1,500 mg/100 mL) (15 mg/mL)
Rx Only
For Intravenous Infusion Only

levetiracetam-spl-bag-3
(click image for full-size original)
LEVETIRACETAM levetiracetam injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-152
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
ACETIC ACID
SODIUM ACETATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68083-152-10 10 BAG in 1 CARTON contains a BAG (68083-152-01)
1 NDC:68083-152-01 100 mL in 1 BAG This package is contained within the CARTON (68083-152-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206880 11/07/2017
LEVETIRACETAM levetiracetam injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-153
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
ACETIC ACID
SODIUM ACETATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68083-153-10 10 BAG in 1 CARTON contains a BAG (68083-153-01)
1 NDC:68083-153-01 100 mL in 1 BAG This package is contained within the CARTON (68083-153-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206880 11/07/2017
LEVETIRACETAM levetiracetam injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-154
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
ACETIC ACID
SODIUM ACETATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68083-154-10 10 BAG in 1 CARTON contains a BAG (68083-154-01)
1 NDC:68083-154-01 100 mL in 1 BAG This package is contained within the CARTON (68083-154-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206880 11/07/2017
Labeler — Gland Pharma Limited (918601238)
Establishment
Name Address ID/FEI Operations
Gland Pharma Limited 918601238 ANALYSIS (68083-152), ANALYSIS (68083-153), ANALYSIS (68083-154), MANUFACTURE (68083-152), MANUFACTURE (68083-153), MANUFACTURE (68083-154)

Revised: 05/2021 Gland Pharma Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

https://medlibrary.org/lib/rx/meds/levetiracetam-127/page/7/

Clinical Trials

MedLibrary.org

Medication Sections

RSS Feeds

About

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.