Levetiracetam (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 5 mL

LevETIRAcetam

Oral Solution, USP

500 mg per 5 mL

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Delivers 5 mL

Store at 20° — 25°C (68° — 77°F); see USP CRT conditions.

XACTDOSE

Distributed by:

VistaPharm, Inc.

Largo, FL 33771, USA

Rx Only

VP2036R2

06/18

NDC 66689-028-01

PRINCIPAL DISPLAY PANEL — 10 mL

LEVETIRACETAM ORAL SOLUTION

1000 mg/ 10 mL

STORE AT 20° — 25° C (68° — 77°F)

[SEE USP CONTROLLED RM TEMP]

10 mL

Manufactured by:

VistaPharm, Inc.

Largo, FL 33771 USA

Rx Only

VP2037R1

NDC 66689-029-01

PRINCIPAL DISPLAY PANEL — 10 mL — 20 per Case

LevETIRAcetam

Oral Solution, USP

1000 mg per 10 mL

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Delivers 10 mL

Store at 20°-25°C (68°-77°F); see USP CRT conditions.

XACTDOSE

Distributed by:

VistaPharm, Inc.

Largo, FL 33771, USA

Rx Only

VP2528

10/20

NDC 66689-102-01

PRINCIPAL DISPLAY PANEL — 15 mL

LEVETIRACETAM ORAL SOLUTION

1500 mg/ 15 mL

STORE AT 20° — 25° C (68° — 77°F)

[SEE USP CONTROLLED RM TEMP]

15 mL

Manufactured by:

VistaPharm, Inc.

Largo, FL 33771 USA

Rx Only

VP2038R1

NDC 66689-030-01

LEVETIRACETAM levetiracetam solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-028(NDC:0472-0235) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM AMMONIUM GLYCYRRHIZATE CITRIC ACID MONOHYDRATE GLYCERIN MALTITOL METHYLPARABEN PROPYLPARABEN WATER TRISODIUM CITRATE DIHYDRATE

Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66689-028-50 5 TRAY in 1 CASE contains a TRAY 1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-028-50) and contains a CUP, UNIT-DOSE (66689-028-01) 1 NDC:66689-028-01 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-028-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078976 01/25/2010

LEVETIRACETAM levetiracetam solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-029 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 100 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66689-029-50 5 TRAY in 1 CASE contains a TRAY 1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-029-50) and contains a CUP, UNIT-DOSE (66689-029-01) 1 NDC:66689-029-01 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-029-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078976 01/25/2010

LEVETIRACETAM levetiracetam solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-030 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 100 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66689-030-50 5 TRAY in 1 CASE contains a TRAY 1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-030-50) and contains a CUP, UNIT-DOSE (66689-030-01) 1 NDC:66689-030-01 15 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-030-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078976 01/25/2010

LEVETIRACETAM levetiracetam solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-102 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 100 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66689-102-20 2 TRAY in 1 CASE contains a TRAY 1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-102-20) and contains a CUP, UNIT-DOSE (66689-102-01) 1 NDC:66689-102-01 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-102-20)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078976 02/24/2021

Labeler — VistaPharm, Inc. (116743084)

Revised: 02/2021 VistaPharm, Inc.