NDC 0832-1218

Jantoven

Warfarin Sodium

Jantoven is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Warfarin Sodium.

Product ID0832-1218_c53792d1-2f38-4285-bca6-f9c40565e4cb
NDC0832-1218
Product TypeHuman Prescription Drug
Proprietary NameJantoven
Generic NameWarfarin Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-02-23
Marketing CategoryANDA / ANDA
Application NumberANDA040416
Labeler NameUpsher-Smith Laboratories, LLC
Substance NameWARFARIN SODIUM
Active Ingredient Strength8 mg/1
Pharm ClassesVitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0832-1218-00

100 TABLET in 1 BOTTLE (0832-1218-00)
Marketing Start Date2010-02-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0832-1218-50 [00832121850]

Jantoven TABLET
Marketing CategoryANDA
Application NumberANDA040416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-23

NDC 0832-1218-89 [00832121889]

Jantoven TABLET
Marketing CategoryANDA
Application NumberANDA040416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-23

NDC 0832-1218-00 [00832121800]

Jantoven TABLET
Marketing CategoryANDA
Application NumberANDA040416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-23

NDC 0832-1218-01 [00832121801]

Jantoven TABLET
Marketing CategoryANDA
Application NumberANDA040416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-23

Drug Details

Active Ingredients

IngredientStrength
WARFARIN SODIUM7.5 mg/1

OpenFDA Data

SPL SET ID:19a69a72-ac5d-45d5-a94d-a5aaecbe4730
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855336
  • 855344
  • 855292
  • 855338
  • 855348
  • 855342
  • 855332
  • 855288
  • 855322
  • 855318
  • 855324
  • 855328
  • 855302
  • 855316
  • 855300
  • 855306
  • 855312
  • 855296
    • UPC Code
  • 0308321217009
  • 0308321212004
  • 0308321211007
  • 0308321215005

    • Pharmacological Class

    • Vitamin K Antagonist [EPC]
    • Vitamin K Inhibitors [MoA]
    • Vitamin K Antagonist [EPC]
    • Vitamin K Inhibitors [MoA]

    NDC Crossover Matching brand name "Jantoven" or generic name "Warfarin Sodium"

    NDCBrand NameGeneric Name
    0832-1217JantovenJantoven
    0832-1213JantovenJantoven
    0832-1216JantovenJantoven
    0832-1218JantovenJantoven
    0832-1211JantovenJantoven
    0832-1219JantovenJantoven
    0832-1215JantovenJantoven
    0832-1212JantovenJantoven
    0832-1214JantovenJantoven
    55154-5619JantovenJantoven
    55154-5620JantovenJantoven
    55154-5621JantovenJantoven
    55154-5618JantovenJantoven
    0056-0168COUMADINwarfarin sodium
    0056-0169COUMADINwarfarin sodium
    0056-0170COUMADINwarfarin sodium
    0056-0172COUMADINwarfarin sodium
    0056-0173COUMADINwarfarin sodium
    0056-0174COUMADINwarfarin sodium
    0056-0176COUMADINwarfarin sodium
    0056-0188COUMADINwarfarin sodium
    0056-0189COUMADINwarfarin sodium
    0093-1712Warfarin SodiumWarfarin Sodium
    0093-1713Warfarin SodiumWarfarin Sodium
    0093-1714Warfarin SodiumWarfarin Sodium
    0093-1715Warfarin SodiumWarfarin Sodium
    0093-1716Warfarin SodiumWarfarin Sodium

    Trademark Results [Jantoven]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    JANTOVEN
    JANTOVEN
    76465738 2858599 Live/Registered
    UPSHER-SMITH LABORATORIES, LLC
    2002-11-12
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.