PRAVASTATIN SODIUM (Page 11 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Pravastatin sodium tablets, USP are supplied as:

20 mg tablets: Yellow coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘2’ on other side. They are supplied in bottles as follows.

NDC Number Size
43063-807-30 Bottle of 30 tablets

16.2 Storage

Store at 25°C (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

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 tablets [see Warnings and Precautions (5.1)].

Liver Enzymes

It is recommended that liver enzyme tests be performed before the initiation of pravastatin sodium tablets, and thereafter when clinically indicated. All patients treated with pravastatin sodium tablets 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 (5.3)].

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 tablets [see Contraindications (4.4), Use in Specific Populations (8.2)] .

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 0983 1 6005285

Issued November 2020

Pravastatin Sodium Tablets USP

20 mg

43063807 Label
(click image for full-size original)
PRAVASTATIN SODIUM pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-807(NDC:16729-009)
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
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM OXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
POVIDONE
Product Characteristics
Color yellow Score no score
Shape RECTANGLE Size 8mm
Flavor Imprint Code PB;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-807-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207068 02/16/2017
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-807)

Revised: 01/2022 PD-Rx Pharmaceuticals, Inc.

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