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
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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
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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
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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

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