NDC 63629-4372

CRESTOR

Rosuvastatin Calcium

CRESTOR 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 ID63629-4372_9a087c00-02c9-48a4-84a5-d215ca9f5101
NDC63629-4372
Product TypeHuman Prescription Drug
Proprietary NameCRESTOR
Generic NameRosuvastatin Calcium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2003-08-18
Marketing CategoryNDA / NDA
Application NumberNDA021366
Labeler NameBryant Ranch Prepack
Substance NameROSUVASTATIN CALCIUM
Active Ingredient Strength5 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63629-4372-1

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-4372-1)
Marketing Start Date2010-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4372-1 [63629437201]

CRESTOR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021366
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-01
Inactivation Date2020-01-31

NDC 63629-4372-2 [63629437202]

CRESTOR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021366
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-09
Marketing End Date2013-06-01
Inactivation Date2020-01-31

NDC 63629-4372-3 [63629437203]

CRESTOR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021366
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-09
Marketing End Date2013-06-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ROSUVASTATIN CALCIUM5 mg/1

OpenFDA Data

SPL SET ID:fa54df87-41d5-96a7-07b6-e700b640bc66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859426
  • 859424

    • 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.