Pravastatin sodium tablet

Ingredients and appearance - Product information

Pravastatin sodium tablet- Pravastatin sodium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 60760-528
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Pravastatin sodium ( UNII: 3M8608UQ61)( Pravastatin - UNII: KXO2KT9N0G ) 40 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone k30 ( UNII: U725QWY32X)
Magnesium aluminum silicate ( UNII: 6M3P64V0NC)
Talc ( UNII: 7SEV7J4R1U)

Product Characteristics

Color white (White to off-white) Size 14 mm
Shape CAPSULE Score 1
Imprint Code PV40


# Item Code Package Description Marketing Start Date
1 NDC: 60760-528-90 90 in 1 BOTTLE, PLASTIC 2017/12/15

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076939 USA 2017/12/15

Labeler - St. Mary's Medical Park Pharmacy( 063050751)


Name ID/FEI Business Operations
St. Mary's Medical Park Pharmacy 063050751 repack( 60760-528), relabel( 60760-528)
The risk reduction due to treatment with pravastatin was consistent in both sexes.
A multicenter, double-blind, placebo-controlled study.
Pooled analysis of 2 multicenter, double-blind, placebo-controlled studies.
The above least-squares mean values were calculated based on log-transformed lipid values.
Significant at p 0.0001 when compared with placebo.