Prescription drug · ANDA
Tolvaptan NDC 0480-3312
Kit · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-3312-66 | 00480331266 | 4 BLISTER PACK in 1 CARTON (0480-3312-66) / 1 KIT in 1 BLISTER PACK (0480-3312-14) * 7 TABLET in 1 BLISTER PACK (0480-4082-11) * 7 TABLET in 1 BLISTER PACK (0480-3265-11)Marketed from Aug 27, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Teva Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216933
- Marketing start
- Listing expires
- Identifiers
- Product ID 0480-3312_55f269ec-f4f3-48c0-a7ea-b5d8a97344d9SPL ID 55f269ec-f4f3-48c0-a7ea-b5d8a97344d9SPL set ID 808a9a1f-2f58-4677-9127-e749ad007094RxCUI 2044359, 2044363, 2044367, 2044966, 2044968, 2044970, 2274813, 2274815, 2719335, 2719337
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
N400480331266followed by a unit qualifier and the quantityPackage 00480-3312-66. 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 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 216933
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.