NDC Code(s) : 68084-500-11, 68084-500-01, 68084-501-11, 68084-501-01, 68084-502-11, 68084-502-01, 68084-746-95, 68084-746-25
Packager : American Health Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

pravastatin sodiumpravastatin sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-500(NDC:68382-070)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM(UNII: 3M8608UQ61)
(PRAVASTATIN - UNII:KXO2KT9N0G) 		PRAVASTATIN SODIUM10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
SODIUM CARBONATE(UNII: 45P3261C7T)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score no score
Shape OVAL (OVAL) Size 9 mm
Flavor Imprint Code ZC46
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-500-01100 in 1 BOX, UNIT-DOSE 11/10/2011
1NDC:68084-500-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077751 10/01/2011 08/31/2017
pravastatin sodiumpravastatin sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-501(NDC:68382-071)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM(UNII: 3M8608UQ61)
(PRAVASTATIN - UNII:KXO2KT9N0G) 		PRAVASTATIN SODIUM20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
SODIUM CARBONATE(UNII: 45P3261C7T)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score no score
Shape OVAL (OVAL) Size 11 mm
Flavor Imprint Code ZC45
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-501-01100 in 1 BOX, UNIT-DOSE 08/09/2011
1NDC:68084-501-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077751 09/01/2011 03/31/2018
pravastatin sodiumpravastatin sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-502(NDC:68382-072)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM(UNII: 3M8608UQ61)
(PRAVASTATIN - UNII:KXO2KT9N0G) 		PRAVASTATIN SODIUM40 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
SODIUM CARBONATE(UNII: 45P3261C7T)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score no score
Shape OVAL (OVAL) Size 14 mm
Flavor Imprint Code ZC44
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-502-01100 in 1 BOX, UNIT-DOSE 13/09/2011
1NDC:68084-502-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077751 09/01/2011 03/31/2018
pravastatin sodiumpravastatin sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-746(NDC:68382-073)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM(UNII: 3M8608UQ61)
(PRAVASTATIN - UNII:KXO2KT9N0G) 		PRAVASTATIN SODIUM80 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
SODIUM CARBONATE(UNII: 45P3261C7T)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score no score
Shape OVAL (OVAL) Size 19 mm
Flavor Imprint Code ZC43
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-746-2530 in 1 BOX, UNIT-DOSE 30/04/2014
1NDC:68084-746-951 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077751 04/30/2014 06/30/2018

PRINCIPAL DISPLAY PANEL

10 mg Pravastatin Carton

NDC 68084-500-01

PRAVASTATIN
SODIUM
Tablets, USP

10 mg

100 Tablets (10 x 10)

Each Tablet Contains:
Pravastatin sodium, USP.............................. 10 mg

Usual Dosage: See package insert for full
prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions
permitted to 15° to 30°C (59° to 86°F) [see USP
Controlled Room Temperature].
Protect from moisture and light.

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from
NDC # 68382-070, Zydus Pharmaceuticals USA Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

050001
Rev. 01/2015

PRINCIPAL DISPLAY PANEL

10 mg Pravastatin Blister

PRAVASTATIN
SODIUM
Tablet, USP

10 mg

PRINCIPAL DISPLAY PANEL

20 mg Pravastatin Carton

NDC 68084-501-01

PRAVASTATIN
SODIUM
Tablets, USP

20 mg

100 Tablets (10 x 10)

Each Tablet Contains:
Pravastatin sodium, USP.............................. 20 mg

Usual Dosage: See package insert for full
prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions
permitted to 15° to 30°C (59° to 86°F) [see USP
Controlled Room Temperature].
Protect from moisture and light.

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from
NDC # 68382-071, Zydus Pharmaceuticals USA Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

050101
Rev. 01/2015

PRINCIPAL DISPLAY PANEL

20 mg Pravastatin Blister

PRAVASTATIN
SODIUM
Tablet, USP

20 mg

PRINCIPAL DISPLAY PANEL

40 mg Pravastatin Carton

NDC 68084-502-01

PRAVASTATIN
SODIUM
Tablets, USP

40 mg

100 Tablets (10 x 10)

Each tablet contains:
Pravastatin sodium, USP................................40 mg

Usual Dosage: See package insert for complete
prescribing information.

Store at 20° to 25°C (68° to 77°F) [See USP
Controlled Room Temperature].
Protect from moisture and light.

Keep this and all drugs out of reach of children.

Rx only

The drug product contained in this package is
from NDC # 68382-072, Zydus Pharmaceuticals
(USA) Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

050201
Rev. 06/2013

PRINCIPAL DISPLAY PANEL

40 mg Pravastatin Blister

PRAVASTATIN
SODIUM
Tablet, USP

40 mg

PRINCIPAL DISPLAY PANEL

80 mg Pravastatin Carton

NDC 68084-746-25

PRAVASTATIN
SODIUM
Tablets, USP

80 mg

30 Tablets (5 x 6)

Each tablet contains:
Pravastatin sodium, USP........................80 mg

Usual Dosage: See package insert for
complete prescribing information.

Store at 20° to 25°C (68° to 77°F) [See USP
Controlled Room Temperature]. Protect
from light and moisture.

Keep this and all drugs out of reach of
children.

Rx Only

The drug product contained in this package
is from NDC # 68382-073, Zydus
Pharmaceuticals (USA) Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

074625
Rev. 03/2014

PRINCIPAL DISPLAY PANEL

80 mg Pravastatin Blister

PRAVASTATIN
SODIUM
Tablet, USP

80 mg