NDC 60505-2886

ROSUVASTATIN

Rosuvastatin Calcium

ROSUVASTATIN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Rosuvastatin Calcium.

Product ID60505-2886_195b28af-0c20-0222-bac1-3495fb0a9db5
NDC60505-2886
Product TypeHuman Prescription Drug
Proprietary NameROSUVASTATIN
Generic NameRosuvastatin Calcium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-08-29
Marketing CategoryANDA / ANDA
Application NumberANDA079145
Labeler NameApotex Corp.
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 60505-2886-8

1000 TABLET, FILM COATED in 1 BOTTLE (60505-2886-8)
Marketing Start Date2017-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-2886-9 [60505288609]

ROSUVASTATIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-29
Marketing End Date2019-02-21

NDC 60505-2886-0 [60505288600]

ROSUVASTATIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-29
Marketing End Date2019-02-21

NDC 60505-2886-5 [60505288605]

ROSUVASTATIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-29
Marketing End Date2019-02-21

NDC 60505-2886-8 [60505288608]

ROSUVASTATIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-29
Marketing End Date2019-02-21

Drug Details

Active Ingredients

IngredientStrength
ROSUVASTATIN CALCIUM10 mg/1

OpenFDA Data

SPL SET ID:bd26b8b9-baad-d988-79ba-3f908a8eaab6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859747
  • 859751
  • 859424
  • 859419
    • UPC Code
  • 0360505288595

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    69238-1148RosuvastatinRosuvastatin
    69238-1146RosuvastatinRosuvastatin
    69238-1147RosuvastatinRosuvastatin
    69238-1149RosuvastatinRosuvastatin
    70518-0986RosuvastatinRosuvastatin
    70518-1219RosuvastatinRosuvastatin
    70518-1601RosuvastatinRosuvastatin
    70518-1384RosuvastatinRosuvastatin
    71205-044RosuvastatinRosuvastatin
    31722-885RosuvastatinRosuvastatin
    31722-882RosuvastatinRosuvastatin
    31722-883RosuvastatinRosuvastatin
    31722-884RosuvastatinRosuvastatin
    50090-2724RosuvastatinRosuvastatin
    50090-2722RosuvastatinRosuvastatin
    50090-2723RosuvastatinRosuvastatin
    50090-2725RosuvastatinRosuvastatin
    50268-711RosuvastatinRosuvastatin
    50268-709RosuvastatinRosuvastatin
    50268-710RosuvastatinRosuvastatin
    55700-574RosuvastatinRosuvastatin
    55700-575RosuvastatinRosuvastatin
    60505-2886ROSUVASTATINROSUVASTATIN
    60505-4505ROSUVASTATINROSUVASTATIN
    60505-2885ROSUVASTATINROSUVASTATIN
    60505-4504ROSUVASTATINROSUVASTATIN
    60505-2888ROSUVASTATINROSUVASTATIN
    60505-2887ROSUVASTATINROSUVASTATIN
    60505-4503ROSUVASTATINROSUVASTATIN
    60505-4502ROSUVASTATINROSUVASTATIN
    61919-786RosuvastatinRosuvastatin
    50228-116RosuvastatinRosuvastatin
    50228-117RosuvastatinRosuvastatin
    50228-119RosuvastatinRosuvastatin
    50228-118RosuvastatinRosuvastatin
    0310-0751CRESTORRosuvastatin calcium
    0310-0752CRESTORRosuvastatin calcium
    0310-0754CRESTORRosuvastatin calcium
    0310-0755CRESTORRosuvastatin calcium
    0310-7560CrestorRosuvastatin calcium
    0310-7570CrestorRosuvastatin calcium
    0310-7580CrestorRosuvastatin calcium
    0310-7590CrestorRosuvastatin calcium
    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
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