NDC 63629-3381

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 ID63629-3381_13d04023-9384-4229-bc28-53fc248b827a
NDC63629-3381
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 Strength10 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-3381-1

30 TABLET, FILM COATED in 1 BOTTLE (63629-3381-1)
Marketing Start Date2010-08-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-3381-4 [63629338104]

CRESTOR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-08-18
Inactivation Date2020-01-31

NDC 63629-3381-3 [63629338103]

CRESTOR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-08-18
Inactivation Date2020-01-31

NDC 63629-3381-1 [63629338101]

CRESTOR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-08-18
Inactivation Date2020-01-31

NDC 63629-3381-2 [63629338102]

CRESTOR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-08-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ROSUVASTATIN CALCIUM10 mg/1

OpenFDA Data

SPL SET ID:1a69848d-95d7-41e8-a3a0-aa5367d4f03b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859747
  • 859749

    • 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
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