FDA.reportPublic FDA data

NDC 0832-1216-89 - 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
0832-1216
Requested NDC
0832-1216-89
Package NDCs from labels
0832-1216-00, 0832-1216-10, 0832-1216-89, 0832-1216-01
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
0832-1216-00Jantoven100 in 1 BOTTLETABLET10013
0832-1216-01Jantoven100 in 1 CARTONTABLET10013
0832-1216-10Jantoven1000 in 1 BOTTLETABLET100013
0832-1216-89Jantoven1 in 1 BLISTER PACKTABLET113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1216JANTOVEN (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
0832-1216-00EA - Each0832-121658f6fd5f-eaa5-4b0a-9f58-8ffec8992dcc12012-07-24
0832-1216-01EA - Each0832-121665b4d812-e61e-4c61-91a0-7b8b81ccdbd712012-07-24
0832-1216-10EA - Each0832-121644ca24b0-4ba6-4e57-bfae-7a4131da79a612012-07-24
0832-1216-89EA - Each0832-12162171c901-02f0-46c9-8c05-4dbe37abeb2e12012-07-24

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 5 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack3aeb6bb1-bc43-4fe7-83f2-36cd0bf461022025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack8eae6b6c-1851-4342-b320-7e18968946582025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepacka1860448-d4ef-40f2-b096-056429ca3aea2025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855288
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepackd166f83b-7052-4dc7-b7d4-47faae7dcaed2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepacke7f78a33-71eb-4aac-ba9d-70f75136fab02025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack694e258d-86bd-440c-870b-a7d27fb1c4672025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
unii: 6153CWM0CL
Warfarin SodiumWARFARINGolden State Medical Supply, Inc.a2f6c9f7-87dc-7428-e053-2995a90a1de62025-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
rxcui: 855296
rxcui: 855344
rxcui: 855302
rxcui: 855288
rxcui: 855338
rxcui: 855318
rxcui: 855312
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMPD-Rx Pharmaceuticals, Inc.21255cd5-3c2e-4574-9620-9347d14256b32025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack4f8afe14-897c-458b-b76f-9bae6fa6110e2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack44077bb7-6007-4c15-bbcd-a7a02ac081ce2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack7f604dc4-c2cd-4b1f-b94d-b5877a1be66b2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855344
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMGolden State Medical Supply, Inc.ba8b4ead-d080-91e7-e053-2995a90a82fe2025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
rxcui: 855296
rxcui: 855344
rxcui: 855302
rxcui: 855288
rxcui: 855338
rxcui: 855318
rxcui: 855312
rxcui: 855332
unii: 6153CWM0CL
JantovenWARFARIN SODIUMUpsher-Smith Laboratories, LLC19a69a72-ac5d-45d5-a94d-a5aaecbe47302025-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040416
ndc (package): 0832-1211-10
ndc (package): 0832-1211-01
ndc (package): 0832-1215-00
ndc (package): 0832-1213-00
ndc (package): 0832-1216-10
ndc (package): 0832-1216-89
ndc (package): 0832-1215-89
ndc (package): 0832-1212-10
ndc (package): 0832-1214-01
ndc (package): 0832-1219-50
ndc (package): 0832-1219-01
ndc (package): 0832-1218-50
ndc (package): 0832-1212-01
ndc (package): 0832-1215-01
ndc (package): 0832-1218-00
ndc (package): 0832-1214-89
ndc (package): 0832-1218-01
ndc (package): 0832-1211-89
ndc (package): 0832-1213-01
ndc (package): 0832-1213-10
ndc (package): 0832-1217-00
ndc (package): 0832-1217-01
ndc (package): 0832-1212-00
ndc (package): 0832-1212-89
ndc (package): 0832-1216-00
ndc (package): 0832-1214-00
ndc (package): 0832-1214-10
ndc (package): 0832-1216-01
ndc (package): 0832-1213-89
ndc (package): 0832-1211-00
ndc (package): 0832-1215-10
ndc (package): 0832-1219-89
ndc (package): 0832-1218-89
ndc (package): 0832-1217-89
ndc (package): 0832-1217-10
ndc (package): 0832-1219-00
ndc (product): 0832-1211
ndc (product): 0832-1217
ndc (product): 0832-1216
ndc (product): 0832-1219
ndc (product): 0832-1218
ndc (product): 0832-1215
ndc (product): 0832-1214
ndc (product): 0832-1213
ndc (product): 0832-1212
ndc11 (package): 00832121689
rxcui: 855324
rxcui: 855292
rxcui: 855342
rxcui: 855296
rxcui: 855344
rxcui: 855302
rxcui: 855316
rxcui: 855322
rxcui: 855288
rxcui: 855338
rxcui: 855328
rxcui: 855306
rxcui: 855318
rxcui: 855348
rxcui: 855312
rxcui: 855300
rxcui: 855332
rxcui: 855336
spl id: 396ff415-9bf2-8f45-e063-6394a90af63e
spl set id: 19a69a72-ac5d-45d5-a94d-a5aaecbe4730
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMTeva Pharmaceuticals USA, Inc.0cbce382-9c88-4f58-ae0f-532a841e8f952025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
rxcui: 855296
rxcui: 855344
rxcui: 855302
rxcui: 855288
rxcui: 855338
rxcui: 855318
rxcui: 855312
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMSun Pharmaceutical Industries, Inc.8ad881e0-ca41-42ad-9d7d-eb85b3a30af02025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
rxcui: 855296
rxcui: 855344
rxcui: 855302
rxcui: 855288
rxcui: 855338
rxcui: 855318
rxcui: 855312
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARINCoupler LLC2f2119e8-f583-ba16-e063-6394a90a13a22025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855344
unii: 6153CWM0CL

Reported adverse events (FAERS/openFDA)#

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