SAVAYSA
- Product NDC
- 65597-202
- 11-digit product format
- 655970202
- Labeler code
- 65597
- Product ID
- 65597-202_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
- 30 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SAVAYSA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EDOXABAN TOSYLATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 32W99UE810 |
| Rxcui | 1599543, 1599549, 1599551, 1599553, 1599555, 1599557 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 65597-202-05 | 2024-02-06 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-07 | 2024-02-06 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-10 | 2024-02-06 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-30 | 2024-02-06 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-50 | 2024-02-06 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-70 | 2024-02-06 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-90 | 2024-02-06 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-07 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-10 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-50 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-70 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 |
| 65597-202-90 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2c88-111a-e063-dadaa90a10e2 | These 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 NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65597-202-05 | SAVAYSA | 50 in 1 CARTON | TABLET, FILM COATED | 50 | | 28 |
| 65597-202-05 | SAVAYSA | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 28 |
| 65597-202-07 | SAVAYSA | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 28 |
| 65597-202-10 | SAVAYSA | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 28 |
| 65597-202-10 | SAVAYSA | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 28 |
| 65597-202-30 | SAVAYSA | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 28 |
| 65597-202-50 | SAVAYSA | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 28 |
| 65597-202-70 | SAVAYSA | 7 in 1 BLISTER PACK | TABLET, FILM COATED | 7 | | 28 |
| 65597-202-90 | SAVAYSA | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 28 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65597-202 | SAVAYSA (EDOXABAN TOSYLATE) TABLET, FILM COATED [DAIICHI SANKYO INC.] | 26 | Current NDC, Legacy NDC, 9 package rows | 20240207_e77d3400-56ad-11e3-949a-0800200c9a66.zip |
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 |
|---|
| 65597-202-05 | 65597020205 | 50 BLISTER PACK in 1 CARTON (65597-202-05) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 50 blister pack | 2015-01-31 | 0000-00-00 | No | No | Current |
| 65597-202-07 | 65597020207 | 7 TABLET, FILM COATED in 1 BOTTLE (65597-202-07) | | 2015-01-31 | 0000-00-00 | No | No | Current |
| 65597-202-10 | 65597020210 | 100 BLISTER PACK in 1 CARTON (65597-202-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2015-01-31 | 0000-00-00 | No | No | Current |
| 65597-202-30 | 65597020230 | 30 TABLET, FILM COATED in 1 BOTTLE (65597-202-30) | | 2015-01-31 | 0000-00-00 | No | No | Current |
| 65597-202-50 | 65597020250 | 500 TABLET, FILM COATED in 1 BOTTLE (65597-202-50) | | 2015-01-31 | 0000-00-00 | No | No | Current |
| 65597-202-70 | 65597020270 | 7 TABLET, FILM COATED in 1 BLISTER PACK (65597-202-70) | | 2015-01-31 | 0000-00-00 | No | No | Current |
| 65597-202-90 | 65597020290 | 90 TABLET, FILM COATED in 1 BOTTLE (65597-202-90) | | 2015-01-31 | 0000-00-00 | No | No | Current |