NDC 65483-991

ZYLOPRIM

Allopurinol

ZYLOPRIM is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Prometheus Laboratories Inc.. The primary component is Allopurinol.

Product ID65483-991_cec6bc7a-f20a-4216-8eb8-67fb1ba15ec7
NDC65483-991
Product TypeHuman Prescription Drug
Proprietary NameZYLOPRIM
Generic NameAllopurinol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1966-08-19
Marketing CategoryNDA / NDA
Application NumberNDA016084
Labeler NamePrometheus Laboratories Inc.
Substance NameALLOPURINOL
Active Ingredient Strength100 mg/1
Pharm ClassesXanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 65483-991-10

100 TABLET in 1 BOTTLE (65483-991-10)
Marketing Start Date1966-08-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65483-991-10 [65483099110]

ZYLOPRIM TABLET
Marketing CategoryNDA
Application NumberNDA016084
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1966-08-19
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
ALLOPURINOL100 mg/1

OpenFDA Data

SPL SET ID:342832b5-1a32-4bea-bc49-ab0fd152154e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197320
  • 213995
  • 197319
  • 213998
  • UPC Code
  • 0365483993103
  • 0365483991109
  • Pharmacological Class

    • Xanthine Oxidase Inhibitor [EPC]
    • Xanthine Oxidase Inhibitors [MoA]

    NDC Crossover Matching brand name "ZYLOPRIM" or generic name "Allopurinol"

    NDCBrand NameGeneric Name
    70199-016ZyloprimZyloprim
    70199-015ZyloprimZyloprim
    70518-0551ZYLOPRIMZYLOPRIM
    65483-991ZYLOPRIMZYLOPRIM
    65483-993ZYLOPRIMZYLOPRIM
    67046-681ZyloprimZyloprim
    0378-0137Allopurinolallopurinol
    0378-0181Allopurinolallopurinol
    0591-5543AllopurinolAllopurinol
    0591-5544AllopurinolAllopurinol
    0603-2115Allopurinolallopurinol
    0603-2116Allopurinolallopurinol
    0615-1592AllopurinolAllopurinol
    0615-1593AllopurinolAllopurinol
    0615-8321AllopurinolAllopurinol
    0615-8385Allopurinolallopurinol
    0904-6571Allopurinolallopurinol
    0904-6572Allopurinolallopurinol
    0904-7041AllopurinolAllopurinol
    10544-545AllopurinolAllopurinol
    10544-547AllopurinolAllopurinol
    10544-911AllopurinolAllopurinol
    16571-883Allopurinolallopurinol
    16571-884Allopurinolallopurinol
    16571-885Allopurinolallopurinol
    16714-041AllopurinolAllopurinol
    16714-042AllopurinolAllopurinol

    Trademark Results [ZYLOPRIM]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZYLOPRIM
    ZYLOPRIM
    72180834 0773095 Live/Registered
    Burroughs Wellcome & Co. (U.S.A.) Inc.
    1963-11-12

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