Simvastatin (Page 9 of 9)

17.3 Pregnancy

Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using simvastatin tablets. Discuss future pregnancy plans with your patients, and discuss when to stop taking simvastatin tablets if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking simvastatin tablets and call their healthcare professional.

17.4 Breastfeeding

Women who are breastfeeding should not use simvastatin tablets. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.

Manufactured For:
Accord Healthcare, Inc.,
1009, Slater Road,
Suite 210-B,
Durham, NC 27703,
USA

Manufactured By:
Intas Pharmaceuticals Limited,
Plot No : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210.
India.

10 1331 8 644882Issued February 2013

Manufactured By:

Intas Pharmaceuticals Limited,

Plot No. 5, 6 & 7, Pharmez,

Sarkhej-Bavla, National Highway No. 8-A,

Near Village Matoda, Tal Sanand,

Ahmedabad — 382 213, Gujarat, India

Repackaged By:

ReadyMeds

Dothan, AL 36301

51 1118 0 700311

Issued July 2011

PRINCIPAL DISPLAY PANEL

20 mg : 30 Tablets

photo 1
(click image for full-size original)

40 mg : 30 Tablets

photo 2
(click image for full-size original)

SIMVASTATIN simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64205-005(NDC:16729-005)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
STARCH, CORN
BUTYLATED HYDROXYANISOLE
TITANIUM DIOXIDE
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
TRIETHYL CITRATE
Product Characteristics
Color RED (Brick Red) Score no score
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code S5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64205-005-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078155 02/26/2008
SIMVASTATIN simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64205-006(NDC:16729-006)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
STARCH, CORN
BUTYLATED HYDROXYANISOLE
TITANIUM DIOXIDE
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
TRIETHYL CITRATE
Product Characteristics
Color RED (Brick Red) Score no score
Shape OVAL (OVAL) Size 14mm
Flavor Imprint Code S6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64205-006-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078155 02/26/2008
Labeler — ReadyMeds (072115132)
Establishment
Name Address ID/FEI Operations
ReadyMeds 072115132 repack (64205-005), repack (64205-006)

Revised: 07/2014 ReadyMeds

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