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 7 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Advanced Redness and Irritation ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea6d7a-a2cd-d26e-e053-2995a90a15f82023-12-22WarningsExact identifier
unii: FZ989GH94E
Walgreens Eye Drops Advanced Relief 15mLDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIWalgreen Company949f5560-fba7-2da8-e053-2995a90a23c22023-12-20WarningsExact identifier
unii: FZ989GH94E
Signature Care Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLBetter Living Brands LLC5d7228ce-f108-4cc2-9aec-8b4548c3a1552023-12-20WarningsExact identifier
unii: FZ989GH94E
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
unii: FZ989GH94E
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
unii: FZ989GH94E
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
unii: FZ989GH94E
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: FZ989GH94E
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: FZ989GH94E
Warfarin SodiumWARFARINBryant Ranch Prepack3dd9f8ce-75e0-426a-9d22-6af7742a0ca72023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: FZ989GH94E
Warfarin SodiumWARFARINBryant Ranch Prepackaddaac3d-6fb5-484f-8535-04eb410d2bf02023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: H3R47K3TBD
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions35bf53df-994b-4c32-8bdb-9227e8e195c62023-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARINBryant Ranch Prepackc41b7c23-8053-428a-ac1d-8395e714c2f12023-04-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855318
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMProficient Rx LP388bfa49-f4f7-412a-80ff-d09442489e2b2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMAphena Pharma Solutions - Tennessee, LLCe73d37f8-8a28-4d93-9529-fd1e2c84228a2021-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMAphena Pharma Solutions - Tennessee, LLC2c8f47c6-a180-4ad8-b962-04069d2270cb2021-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLC52b3c2f6-b5ca-44ae-bdcc-552d5191034f2021-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL

Reported adverse events (FAERS/openFDA)#

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