NDC 70786-0004-3
API & Excipient Details

Simvastatin marketed by Unit Dose Services under NDC Code 70786-0004-3

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SIMVASTATIN(UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)	SIMVASTATIN	40 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70786-0006-1	30 in 1 BOTTLE Type 0: Not a Combination Product	08/03/2016
2	NDC:70786-0006-3	90 in 1 BOTTLE Type 0: Not a Combination Product	08/03/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SIMVASTATIN(UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)	SIMVASTATIN	20 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70786-0005-3	90 in 1 BOTTLE Type 0: Not a Combination Product	07/04/2016
2	NDC:70786-0005-1	30 in 1 BOTTLE Type 0: Not a Combination Product	07/04/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SIMVASTATIN(UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)	SIMVASTATIN	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70786-0004-1	30 in 1 BOTTLE Type 0: Not a Combination Product	08/03/2016
2	NDC:70786-0004-3	90 in 1 BOTTLE Type 0: Not a Combination Product	08/03/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078155	02/26/2008

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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