Pravastatin Sodium: Package Insert and Label Information (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Pravastatin Sodium Tablets, USP are supplied as:

Strength	How Supplied	NDC	Tablet Description
10 mg of pravastatin sodium, USP	bottles of 90	68462-195-90	yellow colored, circular shaped, flat faced tablets with “G5” debossed on one side and “10” debossed on the other side. Bottles contain a desiccant canister.
	bottles of 500	68462-195-05
20 mg of pravastatin sodium, USP	bottles of 90	68462-196-90	yellow, rounded-rectangular, biconvex tablets with “G5” debossed on one side and “20” debossed on the other side. Bottles contain a desiccant canister.
	bottles of 500	68462-196-05
40 mg of pravastatin sodium, USP	bottles of 90	68462-197-90	green, rounded-rectangular, biconvex tablets with “G5” debossed on one side and “40” debossed on the other side. Bottles contain a desiccant canister.
	bottles of 500	68462-197-05
80 mg of pravastatin sodium, USP	bottles of 90	68462-198-90	yellow, oval, biconvex tablets with “G5” debossed on one side and “80” debossed on the other side. Bottles contain a desiccant canister.
	bottles of 500	68462-198-05

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

17 PATIENT COUNSELING INFORMATION

Myopathy and Rhabdomyolysis

Advise patients that pravastatin sodium tablets may cause myopathy and rhabdomyolysis. Inform patients that the risk is increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1), Drug Interactions (7.1)].

Hepatic Dysfunction

Inform patients that pravastatin sodium tablets 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 pravastatin sodium tablets. 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 may 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 pravastatin sodium tablets should be discontinued [see Use in Specific Populations (8.1) ].

Lactation

Advise patients that breastfeeding is not recommended during treatment with pravastatin sodium tablets [see Use in Specific Populations (8.2) ].

Manufactured for:

Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

July 2022

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PRAVASTATIN SODIUM pravastatin sodium tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-195 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 10 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSPOVIDONE (15 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MANNITOL MEGLUMINE MICROCRYSTALLINE CELLULOSE STARCH, CORN D&C YELLOW NO. 10

Product Characteristics Color YELLOW Score no score Shape ROUND Size 6mm Flavor Imprint Code G5;10 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68462-195-90 90 TABLET in 1 BOTTLE None 2 NDC:68462-195-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077987 05/11/2007

PRAVASTATIN SODIUM pravastatin sodium tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-196 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 20 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSPOVIDONE (15 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MANNITOL MEGLUMINE MICROCRYSTALLINE CELLULOSE STARCH, CORN D&C YELLOW NO. 10

Product Characteristics Color YELLOW Score no score Shape RECTANGLE (Rounded rectangular) Size 8mm Flavor Imprint Code G5;20 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68462-196-90 90 TABLET in 1 BOTTLE None 2 NDC:68462-196-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077987 05/11/2007

PRAVASTATIN SODIUM pravastatin sodium tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-197 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 40 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSPOVIDONE (15 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MANNITOL MEGLUMINE MICROCRYSTALLINE CELLULOSE STARCH, CORN D&C YELLOW NO. 10 FD&C BLUE NO. 1

Product Characteristics Color GREEN Score no score Shape RECTANGLE (Rounded rectangular) Size 10mm Flavor Imprint Code G5;40 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68462-197-90 90 TABLET in 1 BOTTLE None 2 NDC:68462-197-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077987 05/11/2007

PRAVASTATIN SODIUM pravastatin sodium tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-198 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 80 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSPOVIDONE (15 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MANNITOL MEGLUMINE MICROCRYSTALLINE CELLULOSE STARCH, CORN D&C YELLOW NO. 10

Product Characteristics Color YELLOW Score no score Shape OVAL Size 18mm Flavor Imprint Code G5;80 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68462-198-90 90 TABLET in 1 BOTTLE None 2 NDC:68462-198-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077987 12/28/2007

Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)

Establishment
Name	Address	ID/FEI	Operations
Glenmark Pharmaceuticals Limited		677318665	ANALYSIS (68462-195), ANALYSIS (68462-196), ANALYSIS (68462-197), ANALYSIS (68462-198), MANUFACTURE (68462-195), MANUFACTURE (68462-196), MANUFACTURE (68462-197), MANUFACTURE (68462-198)

Establishment
Name	Address	ID/FEI	Operations
Glenmark Pharmaceuticals Limited		862603186	ANALYSIS (68462-195), ANALYSIS (68462-196), ANALYSIS (68462-197), ANALYSIS (68462-198), MANUFACTURE (68462-195), MANUFACTURE (68462-196), MANUFACTURE (68462-197), MANUFACTURE (68462-198)

Establishment
Name	Address	ID/FEI	Operations
Glenmark Pharmaceuticals Inc., USA		079922908	MANUFACTURE (68462-195), MANUFACTURE (68462-196), MANUFACTURE (68462-197), MANUFACTURE (68462-198), ANALYSIS (68462-195), ANALYSIS (68462-198), ANALYSIS (68462-198), ANALYSIS (68462-198)

Revised: 07/2022 Glenmark Pharmaceuticals Inc., USA