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 3 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.3f1c3083-91d1-488c-ad07-b198fda21da62026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855338
unii: 6153CWM0CL
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.748ebea5-c65b-4b5a-b237-f4eb880865fa2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855344
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.b1bd0d02-eccb-4449-82b9-9b552835029e2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLC4f276251-49b7-438f-9c47-f1cdfc47e5192026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
rxcui: 855296
rxcui: 855344
rxcui: 855302
rxcui: 855288
rxcui: 855318
rxcui: 855312
rxcui: 855332
unii: 6153CWM0CL
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Large Intestine Formula 2103LARGE INTESTINE FORMULAProfessional Complementary Health Formulas532eb4c6-0f3f-4853-89e2-43168e118d652026-01-08WarningsExact identifier
unii: XM0M87F357
Geopathic Stress Drops 2096GEOPATHIC STRESS DROPSProfessional Complementary Health Formulas7d7302b8-3959-4e1e-ad1f-88d265ba9d322026-01-08WarningsExact identifier
unii: XM0M87F357
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf32d3578-0c90-567c-e053-2a95a90a23b82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855288
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf32dd451-3f7a-815b-e053-2995a90a528f2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf86fe457-a1b6-e54d-e053-6294a90a9bc72026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
unii: FZ989GH94E
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
unii: FZ989GH94E
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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