NDC 71335-0302

Rosuvastatin calcium

Rosuvastatin Calcium

Rosuvastatin calcium is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Rosuvastatin Calcium.

Product ID71335-0302_5de6500c-4e2b-4c54-90ce-34c48d437dd6
NDC71335-0302
Product TypeHuman Prescription Drug
Proprietary NameRosuvastatin calcium
Generic NameRosuvastatin Calcium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA206434
Labeler NameBryant Ranch Prepack
Substance NameROSUVASTATIN CALCIUM
Active Ingredient Strength20 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71335-0302-1

30 TABLET, FILM COATED in 1 BOTTLE (71335-0302-1)
Marketing Start Date2018-05-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0302-2 [71335030202]

Rosuvastatin calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206434
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-31
Marketing End Date2019-07-31

NDC 71335-0302-4 [71335030204]

Rosuvastatin calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206434
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-18
Marketing End Date2019-07-31

NDC 71335-0302-1 [71335030201]

Rosuvastatin calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206434
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-31
Marketing End Date2019-07-31

NDC 71335-0302-3 [71335030203]

Rosuvastatin calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206434
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-31
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
ROSUVASTATIN CALCIUM20 mg/1

OpenFDA Data

SPL SET ID:bf40166a-4f73-47ff-938b-2bdbf7f000e4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859747
  • 859751
  • 859424
  • 859419

    • Pharmacological Class

    • HMG-CoA Reductase Inhibitor [EPC]
    • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

    NDC Crossover Matching brand name "Rosuvastatin calcium" or generic name "Rosuvastatin Calcium"

    NDCBrand NameGeneric Name
    0093-7571Rosuvastatin CalciumRosuvastatin Calcium
    0093-7572Rosuvastatin CalciumRosuvastatin Calcium
    0093-7573Rosuvastatin CalciumRosuvastatin Calcium
    0378-2201Rosuvastatin Calciumrosuvastatin calcium
    0378-2203Rosuvastatin Calciumrosuvastatin calcium
    0378-2204Rosuvastatin Calciumrosuvastatin calcium
    0378-2232Rosuvastatin Calciumrosuvastatin calcium
    0781-5400Rosuvastatin calciumRosuvastatin calcium
    67877-440Rosuvastatin CalciumRosuvastatin Calcium
    67877-439Rosuvastatin CalciumRosuvastatin Calcium
    67877-441Rosuvastatin CalciumRosuvastatin Calcium
    67877-442Rosuvastatin CalciumRosuvastatin Calcium
    68071-3349Rosuvastatin CalciumRosuvastatin Calcium
    68071-3348Rosuvastatin CalciumRosuvastatin Calcium
    68071-4765Rosuvastatin calciumRosuvastatin calcium
    68071-4764Rosuvastatin CalciumRosuvastatin Calcium
    68180-731ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM
    68180-730ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM
    68180-732ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM
    68180-733ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM
    68462-262Rosuvastatin CalciumRosuvastatin Calcium
    68462-263Rosuvastatin CalciumRosuvastatin Calcium
    68462-264Rosuvastatin CalciumRosuvastatin Calcium
    68462-261Rosuvastatin CalciumRosuvastatin Calcium
    68788-7310Rosuvastatin CalciumRosuvastatin Calcium
    68788-6823Rosuvastatin CalciumRosuvastatin Calcium
    68788-7086Rosuvastatin calciumRosuvastatin calcium
    68788-6955Rosuvastatin calciumRosuvastatin calcium
    69539-007Rosuvastatin CalciumRosuvastatin Calcium
    69539-008Rosuvastatin CalciumRosuvastatin Calcium
    69539-009Rosuvastatin CalciumRosuvastatin Calcium
    69539-010Rosuvastatin CalciumRosuvastatin Calcium
    70377-007Rosuvastatin calciumRosuvastatin calcium
    70377-006Rosuvastatin CalciumRosuvastatin Calcium
    70377-008Rosuvastatin calciumRosuvastatin calcium
    70518-0002Rosuvastatin CalciumRosuvastatin Calcium
    70377-009Rosuvastatin calciumRosuvastatin calcium
    70518-0404Rosuvastatin calciumRosuvastatin calcium
    70518-0484Rosuvastatin calciumRosuvastatin calcium
    70518-0375Rosuvastatin calciumRosuvastatin calcium
    70518-0167Rosuvastatin CalciumRosuvastatin Calcium
    70518-1169Rosuvastatin calciumRosuvastatin calcium
    70518-0933Rosuvastatin calciumRosuvastatin calcium
    70518-0963Rosuvastatin calciumRosuvastatin calcium
    70518-0987Rosuvastatin CalciumRosuvastatin Calcium
    70518-1311Rosuvastatin calciumRosuvastatin calcium
    70518-1444Rosuvastatin CalciumRosuvastatin Calcium
    70518-1745Rosuvastatin calciumRosuvastatin calcium
    70518-1819Rosuvastatin CalciumRosuvastatin Calcium
    70518-1726Rosuvastatin CalciumRosuvastatin Calcium
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