NDC 69539-008

Rosuvastatin Calcium

Rosuvastatin Calcium

Rosuvastatin Calcium is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Msn Laboratories Private Limited. The primary component is Rosuvastatin Calcium.

Product ID69539-008_3d8b97a5-b9b0-421d-9e51-3ea72a9e24aa
NDC69539-008
Product TypeHuman Prescription Drug
Proprietary NameRosuvastatin Calcium
Generic NameRosuvastatin Calcium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-11-22
Marketing CategoryANDA / ANDA
Application NumberANDA208898
Labeler NameMSN LABORATORIES PRIVATE LIMITED
Substance NameROSUVASTATIN CALCIUM
Active Ingredient Strength10 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69539-008-05

500 TABLET, FILM COATED in 1 BOTTLE (69539-008-05)
Marketing Start Date2019-02-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69539-008-99 [69539000899]

Rosuvastatin Calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-22

NDC 69539-008-05 [69539000805]

Rosuvastatin Calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-25

NDC 69539-008-90 [69539000890]

Rosuvastatin Calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-22

NDC 69539-008-11 [69539000811]

Rosuvastatin Calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-22

NDC 69539-008-06 [69539000806]

Rosuvastatin Calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-22

Drug Details

Active Ingredients

IngredientStrength
ROSUVASTATIN CALCIUM10 mg/1

OpenFDA Data

SPL SET ID:ec43549b-a0c6-4350-9568-8ebf1766303b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859747
  • 859751
  • 859424
  • 859419
    • UPC Code
  • 0369539008117
  • 0369539009992
  • 0369539009053
  • 0369539007998
  • 0369539010905
  • 0369539008995
  • 0369539009114
  • 0369539010059

    • 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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