Prescription drug · ANDA
Tolvaptan NDC 72205-130
Tolvaptan 15 mg/1 · Tablet · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-130-11 | 72205013011 | 1 BLISTER PACK in 1 CARTON (72205-130-11) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 26, 2023 |
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
- Active ingredients
- Tolvaptan — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216949
- Marketing start
- Listing expires
- Other FDA classes
- Vasopressin V2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72205-130_92ce12f1-eae0-4c83-9a4e-a5181e08fa92SPL ID 92ce12f1-eae0-4c83-9a4e-a5181e08fa92SPL set ID 92ce12f1-eae0-4c83-9a4e-a5181e08fa92RxCUI 849827, 849833UNII 21G72T1950UPC 0372205130111, 0372205131118
- 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
N472205013011followed by a unit qualifier and the quantityPackage 72205-0130-11. 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 for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Limitations of Use Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients. Tolvaptan tablets are a selective vasopressin V 2 -recepto…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216949
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.