FDA.reportPublic FDA data

NDC 0832-1213-89 - Jantoven

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0832-1213
Requested NDC
0832-1213-89
Package NDCs from labels
0832-1213-00, 0832-1213-10, 0832-1213-89, 0832-1213-01
Manufacturer
Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals, Inc
Effective date
2025-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Jantoven - Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals, IncUpsher-Smith Laboratories, LLC | Bora Pharmaceuticals, Inc2025-07-08HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-1213-00Jantoven100 in 1 BOTTLETABLET10013
0832-1213-01Jantoven100 in 1 CARTONTABLET10013
0832-1213-10Jantoven1000 in 1 BOTTLETABLET100013
0832-1213-89Jantoven1 in 1 BLISTER PACKTABLET113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1213JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, LLC]12Current NDC, Legacy NDC, 4 package rows20230413_19a69a72-ac5d-45d5-a94d-a5aaecbe4730.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-1213-00EA - Each0832-121368d654a7-6219-4faa-859d-8e32262ca7d612012-07-24
0832-1213-01EA - Each0832-121342ebd13f-3f20-484b-96a7-b988e93b519b12012-07-24
0832-1213-10EA - Each0832-1213f9921e4c-692f-416e-bc8a-1a1a17bd7d1212012-07-24
0832-1213-89EA - Each0832-1213210c8d8d-b05b-413e-850c-e28d5833ecb112012-07-24

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Warfarin SodiumWARFARINCoupler LLC5a5b5e3a-6556-a542-e063-6294a90a6d3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMCardinal Health 107, LLC7c4deb97-9966-4c8e-9ba6-bb260b71e1302026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARINCoupler LLC598e5e2e-9264-8371-e063-6394a90aaf182026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855318
unii: 6153CWM0CL
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.bd6ea120-5d1c-4815-94f2-81e28dc6b7a92026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855318
unii: 6153CWM0CL
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.724b0061-f42a-4008-a078-09c800ee97852026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855288
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.d7fb4290-ed37-4ed3-ae51-c400191961dc2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855338
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.51e98fb6-ba76-497e-95d8-fe895ef0b7ed2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.a4cf3107-5646-4b91-8aae-94548e4409ef2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855288
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.2fb8b8d5-f643-4069-8e47-5eae31a8fbc82026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855344
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.884cdbf6-0a52-4126-8e14-b0d7c9367e332026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855318
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.8eddba53-19c4-411b-b0d4-cb2f948ba1252026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.2cbcc99d-9107-4d39-a1e9-e19305de8b5d2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.8ee94789-72d2-4c42-9dbd-0501e9767d972026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.545ec40d-2db1-4581-b3ec-ce195e5f54002026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
unii: 6153CWM0CL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.