NDC Code(s) : 70786-0006-1, 70786-0006-3, 70786-0005-3, 70786-0005-1, 70786-0004-1, 70786-0004-3
Packager : Unit Dose Services

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

simvastatinsimvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70786-0006(NDC:16729-006)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN(UNII: AGG2FN16EV)
(SIMVASTATIN - UNII:AGG2FN16EV) 		SIMVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color red (Brick Red) Score no score
Shape OVAL (OVAL) Size 14 mm
Flavor Imprint Code S6
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70786-0006-1 30 in 1 BOTTLE Type 0: Not a Combination Product08/03/2016
2NDC:70786-0006-3 90 in 1 BOTTLE Type 0: Not a Combination Product08/03/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078155 02/26/2008
simvastatinsimvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70786-0005(NDC:16729-005)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN(UNII: AGG2FN16EV)
(SIMVASTATIN - UNII:AGG2FN16EV) 		SIMVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color red (Brick Red) Score no score
Shape OVAL (OVAL) Size 11 mm
Flavor Imprint Code S5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70786-0005-3 90 in 1 BOTTLE Type 0: Not a Combination Product07/04/2016
2NDC:70786-0005-1 30 in 1 BOTTLE Type 0: Not a Combination Product07/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078155 02/26/2008
simvastatinsimvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70786-0004(NDC:16729-004)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN(UNII: AGG2FN16EV)
(SIMVASTATIN - UNII:AGG2FN16EV) 		SIMVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color red (Brick Red) Score no score
Shape OVAL (OVAL) Size 8 mm
Flavor Imprint Code S4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70786-0004-1 30 in 1 BOTTLE Type 0: Not a Combination Product08/03/2016
2NDC:70786-0004-3 90 in 1 BOTTLE Type 0: Not a Combination Product08/03/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078155 02/26/2008

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