Pravastatin Sodium (Page 9 of 9)

16.2 Storage

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

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

17 PATIENT COUNSELING INFORMATION

Muscle Pain

Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing pravastatin sodium [see Warnings and Precautions (5.1)].

Liver Enzymes

It is recommended that liver enzyme tests be performed before the initiation of pravastatin sodium, and thereafter when clinically indicated. All patients treated with pravastatin sodium should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.2)].

Embryofetal Toxicity

Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4.3), Use in Specific Populations (8.1, 8.3)].

Lactation

Advise women not to breastfeed during treatment with pravastatin sodium [see Contraindications (4.4), Use in Specific Populations (8.2)].

Manufactured for:

AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 08/16
AV Rev. 09/18 (P)

Label — 10mg

Label 1
(click image for full-size original)

Label — 20mg

Label 20mg
(click image for full-size original)

Label — 40mg

Label 3
(click image for full-size original)

Label — 80mg

Label4
(click image for full-size original)

PRAVASTATIN SODIUM
pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-665(NDC:0093-0771)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSPOVIDONE (15 MPA.S AT 5%)
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
SODIUM STEARYL FUMARATE
Product Characteristics
Color pink Score no score
Shape ROUND Size 7mm
Flavor Imprint Code TEVA;771
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-665-90 90 TABLET in 1 BOTTLE None
2 NDC:42291-665-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076056 06/30/2014
PRAVASTATIN SODIUM
pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-667(NDC:0093-7201)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSPOVIDONE (15 MPA.S AT 5%)
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow (light-yellow) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code TEVA;7201
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-667-90 90 TABLET in 1 BOTTLE None
2 NDC:42291-667-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076056 06/30/2014
PRAVASTATIN SODIUM
pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-668(NDC:0093-7202)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSPOVIDONE (15 MPA.S AT 5%)
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
FD&C BLUE NO. 1
D&C YELLOW NO. 10
Product Characteristics
Color green (light-green) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code TEVA;7202
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-668-90 90 TABLET in 1 BOTTLE None
2 NDC:42291-668-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076056 06/30/2014
PRAVASTATIN SODIUM
pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-669(NDC:0093-7270)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSPOVIDONE (15 MPA.S AT 5%)
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
MAGNESIUM STEARATE
Product Characteristics
Color white (off-white to mottled grey) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code TEVA;7270
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-669-90 90 TABLET in 1 BOTTLE None
2 NDC:42291-669-10 1000 TABLET in 1 BOTTLE None
3 NDC:42291-669-45 45 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077793 06/30/2014
Labeler — AvKARE (796560394)

Revised: 10/2021 AvKARE

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