NDC Code(s) : 71610-250-30, 71610-250-45, 71610-250-60
Packager : Aphena Pharma Solutions - Tennessee, LLC

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:71610-250(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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
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:71610-250-3030 in 1 BOTTLE Type 0: Not a Combination Product14/03/2019
2NDC:71610-250-4545 in 1 BOTTLE Type 0: Not a Combination Product14/03/2019
3NDC:71610-250-6090 in 1 BOTTLE Type 0: Not a Combination Product14/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078155 02/26/2008

LABELER - Aphena Pharma Solutions - Tennessee, LLC(128385585)

Establishment
Name Address ID/FEI Business Operations
Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-250)

PRINCIPAL DISPLAY PANEL

NDC 71610-250 - Simvastatin, USP 10 mg Tablets - Rx Only
Bottle Label 10 mg