FDA.reportPublic FDA data

Jantoven

Product NDC
0832-1214
11-digit product format
008321214
Labeler code
0832
Product ID
0832-1214_396ff415-9bf2-8f45-e063-6394a90af63e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA040416
Marketing category
ANDA
Marketing start
2010-02-23
Substance
WARFARIN SODIUM
Active strength
3 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Jantoven
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855288, 855292, 855296, 855300, 855302, 855306, 855312, 855316, 855318, 855322, 855324, 855328, 855332, 855336, 855338, 855342, 855344, 855348

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
abcfe2f4-1eca-fdc3-341b-b8134a1aec1fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-1214-00Jantoven100 in 1 BOTTLETABLET10013
0832-1214-01Jantoven100 in 1 CARTONTABLET10013
0832-1214-10Jantoven1000 in 1 BOTTLETABLET100013
0832-1214-89Jantoven1 in 1 BLISTER PACKTABLET113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-1214-00EA - Each0832-121413eaedfa-8802-46b2-aea0-951d839e4a1e12012-07-24
0832-1214-01EA - Each0832-1214e2bbd980-0575-4250-b161-a163b2a41a1d12012-07-24
0832-1214-10EA - Each0832-1214bf1cd59c-8485-4dcd-b804-a2d06a76932712012-07-24
0832-1214-89EA - Each0832-1214fd906e71-9aa6-40f9-8a45-d6aa86e60c9212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Warfarin SodiumACTIVE INGREDIENT6153CWM0CLJANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
WarfarinACTIVE MOIETY5Q7ZVV76EIJANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
Brown Iron OxideINACTIVE INGREDIENT1N032N7MFOJANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GJANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDJANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKJANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAJANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTJANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XJANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
magnesium stearateINACTIVE INGREDIENT70097M6I30JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
povidonesINACTIVE INGREDIENTFZ989GH94EJANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7
starch, cornINACTIVE INGREDIENTO8232NY3SJJANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1214JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, LLC]12Current NDC, Legacy NDC, 4 package rows20230413_19a69a72-ac5d-45d5-a94d-a5aaecbe4730.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855292Jantoven 1 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855300Jantoven 10 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855306Jantoven 2 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855316Jantoven 2.5 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855322Jantoven 3 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855328Jantoven 4 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855336Jantoven 5 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855342Jantoven 6 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855348Jantoven 7.5 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855288warfarin sodium 1 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855296warfarin sodium 10 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855302warfarin sodium 2 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855312warfarin sodium 2.5 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855318warfarin sodium 3 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855324warfarin sodium 4 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855332warfarin sodium 5 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855338warfarin sodium 6 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855344warfarin sodium 7.5 MG Oral TabletPSN19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855292warfarin sodium 1 MG Oral Tablet [Jantoven]SBD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855300warfarin sodium 10 MG Oral Tablet [Jantoven]SBD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855306warfarin sodium 2 MG Oral Tablet [Jantoven]SBD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855316warfarin sodium 2.5 MG Oral Tablet [Jantoven]SBD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855322warfarin sodium 3 MG Oral Tablet [Jantoven]SBD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855328warfarin sodium 4 MG Oral Tablet [Jantoven]SBD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855336warfarin sodium 5 MG Oral Tablet [Jantoven]SBD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855342warfarin sodium 6 MG Oral Tablet [Jantoven]SBD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855348warfarin sodium 7.5 MG Oral Tablet [Jantoven]SBD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855288warfarin sodium 1 MG Oral TabletSCD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855296warfarin sodium 10 MG Oral TabletSCD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855302warfarin sodium 2 MG Oral TabletSCD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855312warfarin sodium 2.5 MG Oral TabletSCD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855318warfarin sodium 3 MG Oral TabletSCD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855324warfarin sodium 4 MG Oral TabletSCD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855332warfarin sodium 5 MG Oral TabletSCD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855338warfarin sodium 6 MG Oral TabletSCD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855344warfarin sodium 7.5 MG Oral TabletSCD19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855292Jantoven 1 MG Oral TabletSY19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855300Jantoven 10 MG Oral TabletSY19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855306Jantoven 2 MG Oral TabletSY19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855316Jantoven 2.5 MG Oral TabletSY19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855322Jantoven 3 MG Oral TabletSY19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855328Jantoven 4 MG Oral TabletSY19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855336Jantoven 5 MG Oral TabletSY19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855342Jantoven 6 MG Oral TabletSY19a69a72-ac5d-45d5-a94d-a5aaecbe473013
855348Jantoven 7.5 MG Oral TabletSY19a69a72-ac5d-45d5-a94d-a5aaecbe473013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-1214-0000832121400100 TABLET in 1 BOTTLE (0832-1214-00) 100 tablet2010-02-230000-00-00NoNoCurrent
0832-1214-0100832121401100 BLISTER PACK in 1 CARTON (0832-1214-01) / 1 TABLET in 1 BLISTER PACK (0832-1214-89) 100 blister pack2010-02-230000-00-00NoNoCurrent
0832-1214-10008321214101000 TABLET in 1 BOTTLE (0832-1214-10) 1000 tablet2010-02-230000-00-00NoNoCurrent
0832-1214-89008321214891 in 1 BLISTER PACKHistorical