WN (TAN) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code MSD;740
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0006-0740-54 90 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0006-0740-31 30 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019766 12/23/1991
ZOCOR
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0735
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color ORANGE (PEACH) Score no score
Shape OVAL Size 9mm
Flavor Imprint Code MSD;735
Contains
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0006-0735-31 30 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0006-0735-54 90 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019766 12/23/1991
Labeler - Merck Sharp & Dohme Corp. (001317601)
Establishment
Name Address ID/FEI Business Operations
Merck Sharp & Dohme Ltd. 212559095 MANUFACTURE(0006-0726, 0006-0543, 0006-0749, 0006-0740, 0006-0735)
Establishment
Name Address ID/FEI Business Operations
MSD International GmbH 989517008 API MANUFACTURE(0006-0726, 0006-0543, 0006-0749, 0006-0740, 0006-0735)
Establishment
Name Address ID/FEI Business Operations
Merck Sharp & Dohme Corp. 101740835 PACK(0006-0726, 0006-0543, 0006-0749, 0006-0740, 0006-0735
|
