NDC 67544-555

TOPROL XL

Metoprolol Succinate

TOPROL XL is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Metoprolol Succinate.

Product ID67544-555_c0c40b32-61c4-4f74-a388-b2459593531f
NDC67544-555
Product TypeHuman Prescription Drug
Proprietary NameTOPROL XL
Generic NameMetoprolol Succinate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2001-03-26
Marketing CategoryNDA / NDA
Application NumberNDA019962
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameMETOPROLOL SUCCINATE
Active Ingredient Strength25 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67544-555-45

45 TABLET, EXTENDED RELEASE in 1 BOTTLE (67544-555-45)
Marketing Start Date2016-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67544-555-45 [67544055545]

TOPROL XL TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019962
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-24

NDC 67544-555-60 [67544055560]

TOPROL XL TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019962
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-24

NDC 67544-555-51 [67544055551]

TOPROL XL TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019962
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-25

Drug Details

Active Ingredients

IngredientStrength
METOPROLOL SUCCINATE25 mg/1

OpenFDA Data

SPL SET ID:825e0117-2bfb-46b9-a5b5-d7b3abd59412
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 866429
  • 866436
  • 866438
  • 866427

    • Pharmacological Class

    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]
    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]

    NDC Crossover Matching brand name "TOPROL XL" or generic name "Metoprolol Succinate"

    NDCBrand NameGeneric Name
    70347-200TOPROL XLTOPROL XL
    70347-025TOPROL XLTOPROL XL
    70347-100TOPROL XLTOPROL XL
    70347-050TOPROL XLTOPROL XL
    70518-0234TOPROL XLTOPROL XL
    70518-0232TOPROL XLTOPROL XL
    70518-1022TOPROL XLTOPROL XL
    70518-1258TOPROL XLTOPROL XL
    71610-038TOPROL XLTOPROL XL
    71610-035TOPROL XLTOPROL XL
    55154-9609TOPROL XLTOPROL XL
    63629-3636TOPROL XLTOPROL XL
    67544-491TOPROL XLTOPROL XL
    67544-282TOPROL XLTOPROL XL
    67544-555TOPROL XLTOPROL XL
    71610-373TOPROL XLTOPROL XL
    0378-4595Metoprolol Succinatemetoprolol succinate
    0378-4596Metoprolol Succinatemetoprolol succinate
    0378-4597Metoprolol Succinatemetoprolol succinate
    0378-4598Metoprolol Succinatemetoprolol succinate
    0527-2600METOPROLOL SUCCINATEMetoprolol succinate
    0527-2601METOPROLOL SUCCINATEMetoprolol succinate
    0527-2602METOPROLOL SUCCINATEMetoprolol succinate
    0527-2603METOPROLOL SUCCINATEMetoprolol succinate
    0615-6589METOPROLOL SUCCINATEMETOPROLOL SUCCINATE
    0615-6597METOPROLOL SUCCINATEMETOPROLOL SUCCINATE
    0615-6598METOPROLOL SUCCINATEMETOPROLOL SUCCINATE
    0615-7530METOPROLOL SUCCINATEMETOPROLOL SUCCINATE
    0615-7823Metoprolol succinateMetoprolol succinate
    0615-7824Metoprolol succinateMetoprolol succinate
    0615-7825Metoprolol succinateMetoprolol succinate
    0615-8024METOPROLOL SUCCINATEMetoprolol succinate
    0615-8025METOPROLOL SUCCINATEMetoprolol succinate
    0904-6322Metoprolol succinateMetoprolol succinate
    0904-6323Metoprolol succinateMetoprolol succinate
    0904-6324Metoprolol succinateMetoprolol succinate
    0186-1088TOPROLMetoprolol succinate
    0186-1090TOPROLMetoprolol succinate
    0186-1092TOPROLMetoprolol succinate
    0186-1094TOPROLMetoprolol succinate

    Trademark Results [TOPROL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TOPROL
    TOPROL
    85340738 4163512 Live/Registered
    Top Machinery & Equipment (Zhengzhou) Ltd.
    2011-06-08
    TOPROL
    TOPROL
    78385300 not registered Dead/Abandoned
    AstraZeneca LP
    2004-03-16
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.