NDC 69189-0752

CRESTOR

Rosuvastatin Calcium

CRESTOR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Rosuvastatin Calcium.

Product ID69189-0752_2e93067b-bc8b-4b88-b256-59efab5167b5
NDC69189-0752
Product TypeHuman Prescription Drug
Proprietary NameCRESTOR
Generic NameRosuvastatin Calcium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-04-13
Marketing CategoryNDA / NDA
Application NumberNDA021366
Labeler NameAvera McKennan Hospital
Substance NameROSUVASTATIN CALCIUM
Active Ingredient Strength20 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 69189-0752-1

1 TABLET, FILM COATED in 1 DOSE PACK (69189-0752-1)
Marketing Start Date2016-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69189-0752-1 [69189075201]

CRESTOR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021366
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-13
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ROSUVASTATIN CALCIUM20 mg/1

OpenFDA Data

SPL SET ID:598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859751
  • 859753
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0310-0751CRESTORRosuvastatin calcium
    0310-0752CRESTORRosuvastatin calcium
    0310-0754CRESTORRosuvastatin calcium
    0310-0755CRESTORRosuvastatin calcium
    0310-7560CrestorRosuvastatin calcium
    0310-7570CrestorRosuvastatin calcium
    0310-7580CrestorRosuvastatin calcium
    0310-7590CrestorRosuvastatin calcium
    68151-4634CRESTORCRESTOR
    69189-0752CRESTORCRESTOR
    70518-1904CRESTORCRESTOR
    70518-1925CRESTORCRESTOR
    70518-1905CRESTORCRESTOR
    21695-287CrestorCrestor
    21695-288CrestorCrestor
    21695-759CrestorCrestor
    21695-659CrestorCrestor
    35356-413CrestorCrestor
    43353-289CRESTORCRESTOR
    43353-290CRESTORCRESTOR
    43353-031CRESTORCRESTOR
    50090-1097CRESTORCRESTOR
    50090-1621CRESTORCRESTOR
    52959-629CRESTORCRESTOR
    55289-935CRESTORCRESTOR
    55289-932CRESTORCRESTOR
    55154-6924CRESTORCRESTOR
    55154-6921CRESTORCRESTOR
    63629-6372CRESTORCRESTOR
    63629-4372CRESTORCRESTOR
    63629-4311CRESTORCRESTOR
    63629-6924CRESTORCRESTOR
    63629-3381CRESTORCRESTOR
    63629-6427CRESTORCRESTOR
    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

    Trademark Results [CRESTOR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CRESTOR
    CRESTOR
    75878423 2532819 Live/Registered
    IPR PHARMACEUTICALS INC.
    1999-12-21
    CRESTOR
    CRESTOR
    75819391 not registered Dead/Abandoned
    Crest Microsystems Inc.
    1999-10-12
    CRESTOR
    CRESTOR
    75445606 2245933 Live/Registered
    CRESTOR, INC.
    1998-03-05
    CRESTOR
    CRESTOR
    74642072 not registered Dead/Abandoned
    Crest Microsystem Inc.
    1995-03-06

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.