NDC 71335-1098

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 ID71335-1098_0502c1b7-315c-45c5-9b0c-8949c245a39b
NDC71335-1098
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 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 Through2020-12-31

Packaging

NDC 71335-1098-1

30 TABLET, FILM COATED in 1 BOTTLE (71335-1098-1)
Marketing Start Date2019-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1098-1 [71335109801]

Rosuvastatin Calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-15

NDC 71335-1098-3 [71335109803]

Rosuvastatin Calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-15

NDC 71335-1098-2 [71335109802]

Rosuvastatin Calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-15

NDC 71335-1098-4 [71335109804]

Rosuvastatin Calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-15

Drug Details

Active Ingredients

IngredientStrength
ROSUVASTATIN CALCIUM20 mg/1

OpenFDA Data

SPL SET ID:d6645266-9626-430e-bf04-b6426525ae0a
Manufacturer
UNII

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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