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

lidding label -- 5 mL
(click image for full-size original)
Lidding-Label
(click image for full-size original)

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

Lidding Label -- 10 mL
(click image for full-size original)

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

10 mL -- 20 Count UD Cups
(click image for full-size original)

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

Lidding Label -- 15 mL
(click image for full-size original)
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.

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