Prescription drug · NDA
Jynarque (Tolvaptan) NDC 59148-082
Tolvaptan 15 mg/1 · Tablet · Oral · Otsuka America Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59148-082-13 | 5914800821359148008213 | 1 BOTTLE in 1 CARTON (59148-082-13) / 30 TABLET in 1 BOTTLEMarketed from Apr 23, 2018 |
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)
- Jynarque
- Generic name (nonproprietary)
- tolvaptan
- Active ingredients
- Tolvaptan — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Otsuka America Pharmaceutical, Inc.NDC labeler code 59148
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204441
- Marketing start
- Listing expires
- Other FDA classes
- Vasopressin V2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 59148-082_44174b92-3ef7-45b0-8f67-016857b8fc3aSPL ID 44174b92-3ef7-45b0-8f67-016857b8fc3a
- Pharmacologic class
- Vasopressin V2 Receptor Antagonist
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
N459148008213followed by a unit qualifier and the quantityPackage 59148-0082-13. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 59148-082
- What is NDC 59148-082?
- 59148-082 is the product NDC for Jynarque (tolvaptan), Tolvaptan 15 mg/1 tablet, listed with the FDA by Otsuka America Pharmaceutical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jynarque (Tolvaptan).
- What is the active ingredient?
- Tolvaptan.
- Who is the labeler?
- Otsuka America Pharmaceutical, Inc., NDC labeler code 59148. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jynarque?
- 6 other product NDCs are listed under this name. See all Jynarque NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Jynarque products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-079 | 59148-0079-28 |
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-080 | 59148-0080-28 |
| Jynarquetolvaptan | Tolvaptan 30 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-083 | 59148-0083-13 |
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-087 | 59148-0087-28 |
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-088 | 59148-0088-28 |
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-089 | 59148-0089-28 |
Other NDCs under NDA 204441
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 |
|---|---|---|---|---|
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-079 |
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-080 |
| Jynarquetolvaptan | Tolvaptan 30 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-083 |
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-087 |
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-088 |
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-089 |