Prescription Drug Information: Simvastatin (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING


Simvastatin tablets USP, 5 mg are yellow colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘16’ on other side. They are supplied as follows:
Bottles of 1000 (NDC 82009-012-10)
Simvastatin tablets USP, 10 mg are pink colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘17’ on other side. They are supplied as follows:
Bottles of 1000 (NDC 82009-013-10)
Simvastatin tablets USP, 20 mg are brown colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘18’ on other side. They are supplied as follows:
Bottles of 1000 (NDC 82009-014-10)
Simvastatin tablets USP, 40 mg are brick red colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘19’ on other side. They are supplied as follows:
Bottles of 1000 (NDC 82009-015-10)
Simvastatin tablets USP, 80 mg are brick red capsule shaped, film coated tablet, debossed with ‘H’ on one side and ‘20’ on other side. They are supplied as follows:
Bottles of 500 (NDC 82009-016-05)
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container.

17 PATIENT COUNSELING INFORMATION

Myopathy and Rhabdomyolysis
Advise patients that simvastatin may cause myopathy and rhabdomyolysis. Inform patients taking the 80 mg daily dose of simvastatin that they are at an increased risk. Inform patients that the risk is also increased when taking certain types of medication or consuming grapefruit juice and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to inform other healthcare providers prescribing a new medication or increasing the dose of an existing medication that they are taking simvastatin. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Contraindications ( 4), Warnings and Precautions ( 5.1), and Drug Interactions ( 7.1)].
Hepatic Dysfunction
Inform patients that simvastatin may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions ( 5.3)].
Increases in HbA1c and Fasting Serum Glucose Levels
Inform patients that increases in HbA1c and fasting serum glucose levels may occur with simvastatin. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions ( 5.4)].
Pregnancy
Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus. Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if simvastatin should be discontinued [see Use in Specific Populations ( 8.1)].
Lactation
Advise patients that breastfeeding is not recommended during treatment with simvastatin [see Use in Specific Populations ( 8.2)] .
Manufactured for:
Quallent Pharmaceuticals Health LLC
20 Genesis Close
Grand Cayman KY1-1208
Cayman Islands
by: HETERO TM
Hetero Labs Limited
Jeedimetla, Hyderabad — 500 055, India Revised: 04/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Simvastatin tablets 5mg 1000s container label

simvastatin5mg1000scontlabel
(click image for full-size original)

Simvastatin tablets 10mg 1000s container label

simvastatin10mg1000scontlabel
(click image for full-size original)

Simvastatin tablets 20mg 1000s container label

20mg-1000s
(click image for full-size original)

Simvastatin tablets 40mg 1000s container label

simvastatin40mg1000scontlabel
(click image for full-size original)

S imvastatin tablets 80mg 500s container label

80mg-500s
(click image for full-size original)

SIMVASTATIN simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-012
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
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
FERRIC OXIDE YELLOW
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape OVAL Size 6mm
Flavor Imprint Code H;16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-012-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200895 05/26/2022
SIMVASTATIN simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-013
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
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
FERRIC OXIDE YELLOW
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color pink Score no score
Shape OVAL Size 9mm
Flavor Imprint Code H;17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-013-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200895 05/26/2022
SIMVASTATIN simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-014
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
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
FERRIC OXIDE YELLOW
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color brown Score no score
Shape OVAL Size 12mm
Flavor Imprint Code H;18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-014-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200895 05/26/2022
SIMVASTATIN simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-015
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
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
FERRIC OXIDE YELLOW
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color red (Brick Red) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code H;19
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-015-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200895 05/26/2022
SIMVASTATIN simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-016
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
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
FERRIC OXIDE YELLOW
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color red (Brick Red) Score no score
Shape OVAL (Capsule shaped) Size 18mm
Flavor Imprint Code H;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-016-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200895 05/26/2022
Labeler — Quallent Pharmaceuticals Health LLC (815564528)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit III 676162024 manufacture (82009-012), manufacture (82009-013), manufacture (82009-014), manufacture (82009-015), manufacture (82009-016)

Revised: 09/2022 Quallent Pharmaceuticals Health LLC

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