SAVAYSA

Product NDC
65597-203
11-digit product format
655970203
Labeler code
65597
Product ID
65597-203_dc54247c-0158-4cae-b692-914717ab3a67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EDOXABAN TOSYLATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Daiichi Sankyo Inc.
Application
NDA206316
Marketing category
NDA
Marketing start
2015-01-12
Substance
EDOXABAN TOSYLATE
Active strength
60 mg/1
Pharmacologic classes
Factor Xa Inhibitor [EPC], Factor Xa 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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206316-001SAVAYSAEDOXABAN TOSYLATEEQ 15MG BASETABLET / ORALRLD2015-01-08
N206316-002SAVAYSAEDOXABAN TOSYLATEEQ 30MG BASETABLET / ORALRLD2015-01-08
N206316-003SAVAYSAEDOXABAN TOSYLATEEQ 60MG BASETABLET / ORALRLD, RS2015-01-08

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206316-00173652052027-04-18Drug substance2015-01-30
N206316-00191495322028-03-28Drug product2015-12-17
N206316-00273652052027-04-18Drug substance2015-01-30
N206316-00291495322028-03-28Drug product2015-12-17
N206316-00373652052027-04-18Drug substance2015-01-30
N206316-00391495322028-03-28Drug product2015-12-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N206316-001M-142026-10-18
N206316-002M-142026-10-18
N206316-003M-142026-10-18

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-0884e616aacf4f…
2026-08-18 06:07:402026-07N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206316-002SAVAYSAEQ 30MG BASETABLET / ORALRLD2015-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206316-003SAVAYSAEQ 60MG BASETABLET / ORALRLD, RS2015-01-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206316-001SAVAYSAEQ 15MG BASETABLET / ORALRLD2015-01-08301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N206316-00173652052027-04-18Drug substance2015-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N206316-00191495322028-03-28Drug product2015-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N206316-00273652052027-04-18Drug substance2015-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N206316-00291495322028-03-28Drug product2015-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N206316-00373652052027-04-18Drug substance2015-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N206316-00391495322028-03-28Drug product2015-12-1784e616aacf4f…
2026-08-18 06:07:402026-07N206316-00173652052027-04-18Drug substance2015-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N206316-00191495322028-03-28Drug product2015-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N206316-00273652052027-04-18Drug substance2015-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N206316-00291495322028-03-28Drug product2015-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N206316-00373652052027-04-18Drug substance2015-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N206316-00391495322028-03-28Drug product2015-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206316-00173652052027-04-18Drug substance2015-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206316-00191495322028-03-28Drug product2015-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206316-00273652052027-04-18Drug substance2015-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206316-00291495322028-03-28Drug product2015-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206316-00373652052027-04-18Drug substance2015-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206316-00391495322028-03-28Drug product2015-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-00173652052027-04-18Drug substance2015-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-00191495322028-03-28Drug product2015-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-00273652052027-04-18Drug substance2015-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-00291495322028-03-28Drug product2015-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-00373652052027-04-18Drug substance2015-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-00391495322028-03-28Drug product2015-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N206316-00173652052027-04-18Drug substance2015-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206316-00191495322028-03-28Drug product2015-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206316-00273652052027-04-18Drug substance2015-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206316-00291495322028-03-28Drug product2015-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206316-00373652052027-04-18Drug substance2015-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206316-00391495322028-03-28Drug product2015-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-00173652052027-04-18Drug substance2015-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-00191495322028-03-28Drug product2015-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-00273652052027-04-18Drug substance2015-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-00291495322028-03-28Drug product2015-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-00373652052027-04-18Drug substance2015-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-00391495322028-03-28Drug product2015-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206316-00173652052027-04-18Drug substance2015-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206316-00191495322028-03-28Drug product2015-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206316-00273652052027-04-18Drug substance2015-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206316-00291495322028-03-28Drug product2015-12-17b8a1b40f171c…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N206316-001M-142026-10-1884e616aacf4f…
2026-09-14 22:38:342026-08N206316-002M-142026-10-1884e616aacf4f…
2026-09-14 22:38:342026-08N206316-003M-142026-10-1884e616aacf4f…
2026-08-18 06:07:402026-07N206316-001M-142026-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N206316-002M-142026-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N206316-003M-142026-10-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206316-001M-142026-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206316-002M-142026-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206316-003M-142026-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-001M-142026-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-002M-142026-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206316-003M-142026-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N206316-001M-142026-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206316-002M-142026-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206316-003M-142026-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-001M-142026-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-002M-142026-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206316-003M-142026-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206316-001M-142026-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206316-002M-142026-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206316-003M-142026-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206316-001M-142026-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206316-002M-142026-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206316-003M-142026-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206316-001M-142026-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206316-002M-142026-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206316-003M-142026-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206316-001M-142026-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206316-002M-142026-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206316-003M-142026-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206316-001M-142026-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206316-002M-142026-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206316-003M-142026-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206316-001M-142026-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N206316-002M-142026-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N206316-003M-142026-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206316-001M-142026-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206316-002M-142026-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206316-003M-142026-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206316-001M-142026-10-18301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SAVAYSA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EDOXABAN TOSYLATE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
32W99UE810Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1599543Internal RxNorm lookup
1599549Internal RxNorm lookup
1599551Internal RxNorm lookup
1599553Internal RxNorm lookup
1599555Internal RxNorm lookup
1599557Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e77d3400-56ad-11e3-949a-0800200c9a66Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7ccb8a0d-94d2-4928-a2d6-6c827851680fProduct name120150313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
65597-203-052024-02-06These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-072024-02-06These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-102024-02-06These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-302024-02-06These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-502024-02-06These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-702024-02-06These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-902024-02-06These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-052024-01-30These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-072024-01-30These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-102024-01-30These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-302024-01-30These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-502024-01-30These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-702024-01-30These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015
65597-203-902024-01-30These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA ® (edoxaban) tablets, for oral use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65597-203-05SAVAYSA1 in 1 BLISTER PACKTABLET, FILM COATED128
65597-203-05SAVAYSA50 in 1 CARTONTABLET, FILM COATED5028
65597-203-07SAVAYSA7 in 1 BOTTLETABLET, FILM COATED728
65597-203-10SAVAYSA100 in 1 CARTONTABLET, FILM COATED10028
65597-203-10SAVAYSA1 in 1 BLISTER PACKTABLET, FILM COATED128
65597-203-30SAVAYSA30 in 1 BOTTLETABLET, FILM COATED3028
65597-203-50SAVAYSA500 in 1 BOTTLETABLET, FILM COATED50028
65597-203-70SAVAYSA7 in 1 BLISTER PACKTABLET, FILM COATED728
65597-203-90SAVAYSA90 in 1 BOTTLETABLET, FILM COATED9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65597-203-05EA - Each65597-2037208c303-647d-42e8-8c08-d736f9c6a11112015-06-09
65597-203-30EA - Each65597-2035387a252-2326-4f7d-abc7-3ef1bfe78ece12015-02-02
65597-203-90EA - Each65597-203ef34f281-f57d-4e22-aa61-ee67cb89752812015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EDOXABAN TOSYLATEACTIVE INGREDIENT32W99UE810SAVAYSA (EDOXABAN TOSYLATE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]6
EDOXABANACTIVE MOIETYNDU3J18APOSAVAYSA (EDOXABAN TOSYLATE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65597-203SAVAYSA (EDOXABAN TOSYLATE) TABLET, FILM COATED [DAIICHI SANKYO INC.]26Current NDC, Legacy NDC, 9 package rows20240207_e77d3400-56ad-11e3-949a-0800200c9a66.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.e77d3400-56ad-11e3-949a-0800200c9a662025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 206316
application number: NDA206316
ndc (product): 65597-203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599543edoxaban 15 MG Oral TabletPSNe77d3400-56ad-11e3-949a-0800200c9a6628
1599551edoxaban 30 MG Oral TabletPSNe77d3400-56ad-11e3-949a-0800200c9a6628
1599555edoxaban 60 MG Oral TabletPSNe77d3400-56ad-11e3-949a-0800200c9a6628
1599549Savaysa 15 MG Oral TabletPSNe77d3400-56ad-11e3-949a-0800200c9a6628
1599553Savaysa 30 MG Oral TabletPSNe77d3400-56ad-11e3-949a-0800200c9a6628
1599557Savaysa 60 MG Oral TabletPSNe77d3400-56ad-11e3-949a-0800200c9a6628
1599549edoxaban 15 MG Oral Tablet [Savaysa]SBDe77d3400-56ad-11e3-949a-0800200c9a6628
1599553edoxaban 30 MG Oral Tablet [Savaysa]SBDe77d3400-56ad-11e3-949a-0800200c9a6628
1599557edoxaban 60 MG Oral Tablet [Savaysa]SBDe77d3400-56ad-11e3-949a-0800200c9a6628
1599543edoxaban 15 MG Oral TabletSCDe77d3400-56ad-11e3-949a-0800200c9a6628
1599551edoxaban 30 MG Oral TabletSCDe77d3400-56ad-11e3-949a-0800200c9a6628
1599555edoxaban 60 MG Oral TabletSCDe77d3400-56ad-11e3-949a-0800200c9a6628
1599543edoxaban 15 MG (as edoxaban tosylate 20.2 MG) Oral TabletSYe77d3400-56ad-11e3-949a-0800200c9a6628
1599551edoxaban 30 MG (as edoxaban tosylate 40.41 MG) Oral TabletSYe77d3400-56ad-11e3-949a-0800200c9a6628
1599555edoxaban 60 MG (as edoxaban tosylate 80.82 MG) Oral TabletSYe77d3400-56ad-11e3-949a-0800200c9a6628
1599549Savaysa 15 MG (as edoxaban tosylate 20.2 MG) Oral TabletSYe77d3400-56ad-11e3-949a-0800200c9a6628
1599549Savaysa 15 MG Oral TabletSYe77d3400-56ad-11e3-949a-0800200c9a6628
1599553Savaysa 30 MG (as edoxaban tosylate 40.41 MG) Oral TabletSYe77d3400-56ad-11e3-949a-0800200c9a6628
1599553Savaysa 30 MG Oral TabletSYe77d3400-56ad-11e3-949a-0800200c9a6628
1599557Savaysa 60 MG (as edoxaban tosylate 80.82 MG) Oral TabletSYe77d3400-56ad-11e3-949a-0800200c9a6628
1599557Savaysa 60 MG Oral TabletSYe77d3400-56ad-11e3-949a-0800200c9a6628

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65597-203-056559702030550 BLISTER PACK in 1 CARTON (65597-203-05) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2015-01-310000-00-00NoNoCurrent
65597-203-07655970203077 TABLET, FILM COATED in 1 BOTTLE (65597-203-07) 2015-01-310000-00-00NoNoCurrent
65597-203-1065597020310100 BLISTER PACK in 1 CARTON (65597-203-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2015-01-310000-00-00NoNoCurrent
65597-203-306559702033030 TABLET, FILM COATED in 1 BOTTLE (65597-203-30) 2015-01-310000-00-00NoNoCurrent
65597-203-5065597020350500 TABLET, FILM COATED in 1 BOTTLE (65597-203-50) 2015-01-310000-00-00NoNoCurrent
65597-203-70655970203707 TABLET, FILM COATED in 1 BLISTER PACK (65597-203-70) 2015-01-310000-00-00NoNoCurrent
65597-203-906559702039090 TABLET, FILM COATED in 1 BOTTLE (65597-203-90) 2015-01-310000-00-00NoNoCurrent