NDC Code(s) : 0093-0771-98, 0093-0771-10, 0093-7201-98, 0093-7201-10, 0093-7202-98, 0093-7202-10
Packager : Teva Pharmaceuticals USA, Inc.

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:0093-0771
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
Product Characteristics
Color pink Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code TEVA;771
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-0771-9890 in 1 BOTTLE Type 0: Not a Combination Product25/04/2006
2NDC:0093-0771-101000 in 1 BOTTLE Type 0: Not a Combination Product03/07/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076056 04/25/2006
Pravastatin SodiumPravastatin Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7201
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow (light-yellow) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code TEVA;7201
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-7201-9890 in 1 BOTTLE Type 0: Not a Combination Product25/04/2006
2NDC:0093-7201-101000 in 1 BOTTLE Type 0: Not a Combination Product25/04/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076056 04/25/2006
Pravastatin SodiumPravastatin Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7202
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color green (light-green) Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code TEVA;7202
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-7202-9890 in 1 BOTTLE Type 0: Not a Combination Product25/04/2006
2NDC:0093-7202-101000 in 1 BOTTLE Type 0: Not a Combination Product25/04/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076056 04/25/2006

LABELER - Teva Pharmaceuticals USA, Inc.(001627975)

PRINCIPAL DISPLAY PANEL

NDC 0093-0771-98
Pravastatin Sodium Tablets, USP
10 mg
Rx only
90 Tablets

10 mg new label

PRINCIPAL DISPLAY PANEL

NDC 0093-7201-98
Pravastatin Sodium Tablets, USP
20 mg
Rx only
90 TABLETS

20 mg new

PRINCIPAL DISPLAY PANEL

NDC 0093-7202-98
Pravastatin Sodium Tablets, USP
40 mg
Rx only
90 TABLETS

40 mg new