Prescription drug · NDA
Jynarque (tolvaptan) NDC 59148-080
Kit · Otsuka America Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59148-080-28 | 59148008028 | 4 BLISTER PACK in 1 CARTON (59148-080-28) / 1 KIT in 1 BLISTER PACK (59148-080-07)Marketed from Jan 13, 2020 |
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
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204441
- Marketing start
- Listing expires
- Identifiers
- Product ID 59148-080_3be8a6fe-a8d0-43ca-a84d-183b522a3cf4SPL ID 3be8a6fe-a8d0-43ca-a84d-183b522a3cf4SPL set ID 3febc0a1-9e5a-4ce0-843d-210f21d862c4RxCUI 2044355, 2044357, 2044359, 2044361, 2044363, 2044365, 2044367, 2044369, 2044966, 2044967, 2044968, 2044969, 2044970, 2044971, 2274813, 2274814, 2274815, 2274816, 2719335, 2719337UNII 21G72T1950
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N459148008028followed by a unit qualifier and the quantityPackage 59148-0080-28. 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)
JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). JYNARQUE is a selective vasopressin V 2 -receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) ( 1 )
Excerpt only. Read the full label for complete information.
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 | Tolvaptan 15 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-082 |
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-079 |
| Jynarquetolvaptan | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-089 |
| 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 |