Simvastatin

SIMVASTATIN- simvastatin tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-065-16 in bottle of 90 tablets

Simvastatin Tablets USP, 5 mg

Rx only

Simvastatin tablets 5 mg
(click image for full-size original)

NDC 65841-066-16 in bottle of 90 tablets

Simvastatin Tablets USP, 10 mg

Rx only

Simvastatin tablets 10 mg
(click image for full-size original)

NDC 65841-067-16 in bottle of 90 tablets

Simvastatin Tablets USP, 20 mg

Rx only

Simvastatin tablets 20 mg
(click image for full-size original)

NDC 65841-068-16 in bottle of 90 tablets

Simvastatin Tablets USP, 40 mg

Rx only

Simvastatin tablets 40 mg
(click image for full-size original)

NDC 65841-069-16 in bottle of 90 tablets

Simvastatin Tablets USP, 80 mg

Rx only

Simvastatin tablets 80 mg
(click image for full-size original)
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-065
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
ANHYDROUS LACTOSE
ASCORBIC ACID
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE) Score no score
Shape OVAL (OVAL) Size 9mm
Flavor Imprint Code ZA19
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-065-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-065-14 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-065-16 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-065-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65841-065-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077837 12/20/2006
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-066
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
ANHYDROUS LACTOSE
ASCORBIC ACID
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK (PINK) Score no score
Shape OVAL (OVAL) Size 9mm
Flavor Imprint Code ZA20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-066-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-066-14 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-066-16 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-066-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65841-066-10 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:65841-066-24 10000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077837 12/20/2006
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-067
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
ANHYDROUS CITRIC ACID
ANHYDROUS LACTOSE
ASCORBIC ACID
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (BROWN) Score no score
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code ZA21
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-067-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-067-14 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-067-16 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-067-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65841-067-10 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:65841-067-24 10000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077837 12/20/2006
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-068
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
ANHYDROUS CITRIC ACID
ANHYDROUS LACTOSE
ASCORBIC ACID
FERRIC OXIDE RED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK (PINK) Score no score
Shape OVAL (OVAL) Size 14mm
Flavor Imprint Code ZA22
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-068-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-068-14 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-068-16 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-068-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65841-068-10 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:65841-068-40 5000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077837 12/20/2006
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-069
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 80 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
ANHYDROUS LACTOSE
ASCORBIC ACID
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code ZA23
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-069-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-069-14 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-069-16 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-069-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65841-069-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077837 12/20/2006
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-065), ANALYSIS (65841-066), ANALYSIS (65841-067), ANALYSIS (65841-068), ANALYSIS (65841-069), MANUFACTURE (65841-065), MANUFACTURE (65841-066), MANUFACTURE (65841-067), MANUFACTURE (65841-068), MANUFACTURE (65841-069)

Revised: 09/2020 Cadila Healthcare Limited

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