Home NDC 0832-1213 Jantoven
Product NDC 0832-1213
11-digit product format 008321213
Labeler code 0832
Product ID 0832-1213_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 2.5 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 9 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040416-001 JANTOVEN WARFARIN SODIUM 1MG TABLET / ORAL AB 2003-10-02 A040416-002 JANTOVEN WARFARIN SODIUM 2MG TABLET / ORAL AB 2003-10-02 A040416-003 JANTOVEN WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2003-10-02 A040416-004 JANTOVEN WARFARIN SODIUM 3MG TABLET / ORAL AB 2003-10-02 A040416-005 JANTOVEN WARFARIN SODIUM 4MG TABLET / ORAL AB 2003-10-02 A040416-006 JANTOVEN WARFARIN SODIUM 5MG TABLET / ORAL AB 2003-10-02 A040416-007 JANTOVEN WARFARIN SODIUM 6MG TABLET / ORAL AB 2003-10-02 A040416-008 JANTOVEN WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2003-10-02 A040416-009 JANTOVEN WARFARIN SODIUM 10MG TABLET / ORAL AB 2003-10-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 9 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 10 · 378 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A040416-001 JANTOVEN 1MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-002 JANTOVEN 2MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-003 JANTOVEN 2.5MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-004 JANTOVEN 3MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-005 JANTOVEN 4MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-006 JANTOVEN 5MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-007 JANTOVEN 6MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-008 JANTOVEN 7.5MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-009 JANTOVEN 10MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040416-001 JANTOVEN 1MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-002 JANTOVEN 2MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-003 JANTOVEN 2.5MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-004 JANTOVEN 3MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-005 JANTOVEN 4MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-006 JANTOVEN 5MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-007 JANTOVEN 6MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-008 JANTOVEN 7.5MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-009 JANTOVEN 10MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-001 JANTOVEN 1MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-002 JANTOVEN 2MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-003 JANTOVEN 2.5MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-004 JANTOVEN 3MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-005 JANTOVEN 4MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-006 JANTOVEN 5MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-007 JANTOVEN 6MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-008 JANTOVEN 7.5MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-009 JANTOVEN 10MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040416-001 JANTOVEN 1MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-002 JANTOVEN 2MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-003 JANTOVEN 2.5MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-004 JANTOVEN 3MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-005 JANTOVEN 4MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-006 JANTOVEN 5MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-007 JANTOVEN 6MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-008 JANTOVEN 7.5MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-009 JANTOVEN 10MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040416-001 JANTOVEN 1MG TABLET / ORAL AB 2003-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040416-002 JANTOVEN 2MG TABLET / ORAL AB 2003-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040416-003 JANTOVEN 2.5MG TABLET / ORAL AB 2003-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040416-004 JANTOVEN 3MG TABLET / ORAL AB 2003-10-02 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 10 · 378 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Jantoven
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WARFARIN SODIUM 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6153CWM0CL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 18 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855288 Internal RxNorm lookup 855292 Internal RxNorm lookup 855296 Internal RxNorm lookup 855300 Internal RxNorm lookup 855302 Internal RxNorm lookup 855306 Internal RxNorm lookup 855312 Internal RxNorm lookup 855316 Internal RxNorm lookup 855318 Internal RxNorm lookup 855322 Internal RxNorm lookup 855324 Internal RxNorm lookup 855328 Internal RxNorm lookup 855332 Internal RxNorm lookup 855336 Internal RxNorm lookup 855338 Internal RxNorm lookup 855342 Internal RxNorm lookup 855344 Internal RxNorm lookup 855348 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0832-1213-00 Jantoven 100 in 1 BOTTLE TABLET 100 13 0832-1213-01 Jantoven 100 in 1 CARTON TABLET 100 13 0832-1213-10 Jantoven 1000 in 1 BOTTLE TABLET 1000 13 0832-1213-89 Jantoven 1 in 1 BLISTER PACK TABLET 1 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Warfarin Sodium ACTIVE INGREDIENT 6153CWM0CL JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 Warfarin ACTIVE MOIETY 5Q7ZVV76EI JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 Brown Iron Oxide INACTIVE INGREDIENT 1N032N7MFO JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 magnesium stearate INACTIVE INGREDIENT 70097M6I30 JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 povidones INACTIVE INGREDIENT FZ989GH94E JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7 starch, corn INACTIVE INGREDIENT O8232NY3SJ JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-1213 JANTOVEN (WARFARIN SODIUM) TABLET [UPSHER-SMITH LABORATORIES, LLC] 12 Current NDC, Legacy NDC, 4 package rows 20230413_19a69a72-ac5d-45d5-a94d-a5aaecbe4730.zip
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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Jantoven WARFARIN SODIUM Upsher-Smith Laboratories, LLC 19a69a72-ac5d-45d5-a94d-a5aaecbe4730 2025-07-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040416 application number: ANDA040416 ndc (product): 0832-1213
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0832-1213-00 00832121300 100 TABLET in 1 BOTTLE (0832-1213-00) 100 tablet 2010-02-23 0000-00-00 No No Current 0832-1213-01 00832121301 100 BLISTER PACK in 1 CARTON (0832-1213-01) / 1 TABLET in 1 BLISTER PACK (0832-1213-89) 100 blister pack 2010-02-23 0000-00-00 No No Current 0832-1213-10 00832121310 1000 TABLET in 1 BOTTLE (0832-1213-10) 1000 tablet 2010-02-23 0000-00-00 No No Current 0832-1213-89 00832121389 1 in 1 BLISTER PACK Historical