Prescription drug · ANDA
Tolvaptan NDC 70748-243
Kit · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70748-243-13 | 70748024313 | 4 BLISTER PACK in 1 CARTON (70748-243-13) / 1 KIT in 1 BLISTER PACK (70748-243-11)Marketed from May 12, 2025 |
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)
- Tolvaptan
- Generic name (nonproprietary)
- tolvaptan
- Dosage form
- Kit
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216063
- Marketing start
- Listing expires
- Identifiers
- Product ID 70748-243_3e110564-6fd2-4450-a3d2-a5de70b85f2dSPL ID 3e110564-6fd2-4450-a3d2-a5de70b85f2dSPL set ID 9ba38e23-ca66-4406-92af-bbb8fad00e16RxCUI 2044359, 2044363, 2044367, 2044966, 2044968, 2044970, 2274813, 2274815, 2719335, 2719337UNII 21G72T1950UPC 0370748244135, 0370748241134, 0370748240137, 0370748242131, 0370748243138
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
N470748024313followed by a unit qualifier and the quantityPackage 70748-0243-13. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Tolvaptan tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Tolvaptan tablet 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 ANDA 216063
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 |
|---|---|---|---|---|
| Tolvaptan | — | Kit | Lupin Pharmaceuticals, Inc. | 70748-240 |
| Tolvaptan | Tolvaptan 15 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 70748-238 |
| Tolvaptan | Tolvaptan 30 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 70748-239 |
| Tolvaptan | — | Kit | Lupin Pharmaceuticals, Inc. | 70748-241 |
| Tolvaptan | — | Kit | Lupin Pharmaceuticals, Inc. | 70748-242 |
| Tolvaptan | — | Kit | Lupin Pharmaceuticals, Inc. | 70748-244 |