Prescription drug · ANDA
Tolvaptan NDC 67877-920
Kit · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-920-54 | 67877092054 | 4 BLISTER PACK in 1 CARTON (67877-920-54) / 1 KIT in 1 BLISTER PACK (67877-920-14)Marketed from Sep 1, 2026 |
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
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220147
- Marketing start
- Listing expires
- Identifiers
- Product ID 67877-920_2a51dd17-fedf-4168-be2a-337ab74667a8SPL ID 2a51dd17-fedf-4168-be2a-337ab74667a8SPL set ID 82ef58ef-ce46-434e-bf99-89fce51094f1RxCUI 2044359, 2044363, 2044367, 2044966, 2044968, 2044970, 2274813, 2274815, 2719335, 2719337UNII 21G72T1950UPC 0367877921549, 0367877923147, 0367877923543, 0367877922546, 0367877922140, 0367877920146, 0367877924144, 0367877924540, 0367877920542, 0367877921143
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
N467877092054followed by a unit qualifier and the quantityPackage 67877-0920-54. 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 tablet is 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 220147
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 | Ascend Laboratories, LLC | 67877-923 |
| Tolvaptan | — | Kit | Ascend Laboratories, LLC | 67877-921 |
| Tolvaptan | — | Kit | Ascend Laboratories, LLC | 67877-922 |
| Tolvaptan | Tolvaptan 30 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-916 |
| Tolvaptan | Tolvaptan 15 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-915 |
| Tolvaptan | Tolvaptan 90 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-919 |
| Tolvaptan | Tolvaptan 45 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-917 |
| Tolvaptan | Tolvaptan 60 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-918 |
| Tolvaptan | — | Kit | Ascend Laboratories, LLC | 67877-924 |