Prescription drug · NDA
Savaysa (Edoxaban tosylate) NDC 65597-201
Edoxaban tosylate 15 mg/1 · Tablet, Film coated · Oral · Daiichi Sankyo Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65597-201-07 | 65597020107 | 7 TABLET, FILM COATED in 1 BOTTLE (65597-201-07)Marketed from Jan 31, 2015 | |
| 65597-201-10 | 65597020110 | 10 TABLET, FILM COATED in 1 BLISTER PACK (65597-201-10)Marketed from Jan 31, 2015 | |
| 65597-201-30 | 65597020130 | 30 TABLET, FILM COATED in 1 BOTTLE (65597-201-30)Marketed from Jan 31, 2015 | |
| 65597-201-50 | 65597020150 | 500 TABLET, FILM COATED in 1 BOTTLE (65597-201-50)Marketed from Jan 31, 2015 | |
| 65597-201-70 | 65597020170 | 7 TABLET, FILM COATED in 1 BLISTER PACK (65597-201-70)Marketed from Jan 31, 2015 | |
| 65597-201-90 | 65597020190 | 90 TABLET, FILM COATED in 1 BOTTLE (65597-201-90)Marketed from Jan 31, 2015 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Savaysa
- Generic name (nonproprietary)
- edoxaban tosylate
- Active ingredients
- Edoxaban tosylate — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Daiichi Sankyo Inc.NDC labeler code 65597
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206316
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 65597-201_dc54247c-0158-4cae-b692-914717ab3a67SPL ID dc54247c-0158-4cae-b692-914717ab3a67SPL set ID e77d3400-56ad-11e3-949a-0800200c9a66RxCUI 1599543, 1599549, 1599551, 1599553, 1599555, 1599557UNII 32W99UE810UPC 0365597202306, 0365597201309
- Pharmacologic class
- Factor Xa Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465597020107followed by a unit qualifier and the quantityPackage 65597-0201-07. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
SAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) ( 1.1 ) Limitation of Use for NVAF SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) ( 1.1 ) SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant ( 1.2 ) 1.1 Reduction in the Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation SAVAYSA is indicated to reduce the risk of …
Excerpt only. Read the full label for complete information.
About NDC 65597-201
- What is NDC 65597-201?
- 65597-201 is the product NDC for Savaysa (edoxaban tosylate), Edoxaban tosylate 15 mg/1 tablet, film coated, listed with the FDA by Daiichi Sankyo Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Savaysa (Edoxaban tosylate).
- What is the active ingredient?
- Edoxaban tosylate.
- Who is the labeler?
- Daiichi Sankyo Inc., NDC labeler code 65597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Savaysa?
- 2 other product NDCs are listed under this name. See all Savaysa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Savaysa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Savaysaedoxaban tosylate | Edoxaban tosylate 30 mg/1 | Tablet, Film coatedOral | Daiichi Sankyo Inc. | 65597-202 | 65597-0202-0565597-0202-0765597-0202-10+4 more |
| Savaysaedoxaban tosylate | Edoxaban tosylate 60 mg/1 | Tablet, Film coatedOral | Daiichi Sankyo Inc. | 65597-203 | 65597-0203-0565597-0203-0765597-0203-10+4 more |
Other NDCs under NDA 206316
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Savaysaedoxaban tosylate | Edoxaban tosylate 30 mg/1 | Tablet, Film coatedOral | Daiichi Sankyo Inc. | 65597-202 |
| Savaysaedoxaban tosylate | Edoxaban tosylate 60 mg/1 | Tablet, Film coatedOral | Daiichi Sankyo Inc. | 65597-203 |