Samsca (tolvaptan) NDC 59148-020

NDC codes

FDA NDC Directory

Product NDC (as listed)59148-020Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59148-0020Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
59148-020-50	59148002050	1 BLISTER PACK in 1 CARTON (59148-020-50) / 10 TABLET in 1 BLISTER PACKMarketed from May 19, 2009

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): Samsca
Generic name (nonproprietary): tolvaptan
Active ingredients: Tolvaptan — 15 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Otsuka America Pharmaceutical, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022275
Marketing start: May 19, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Vasopressin V2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 59148-020_96cac6b9-6a43-4a69-ae83-fa739f14237dSPL ID 96cac6b9-6a43-4a69-ae83-fa739f14237dSPL set ID 5526617c-c7b9-4556-886d-729bbabbc566RxCUI 849827, 849831, 849833, 849835UNII 21G72T1950
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

N459148002050 followed by a unit qualifier and the quantity

Package 59148-0020-50. 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 May 7, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

SAMSCA ® is 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). SAMSCA is a selective vasopressin V 2 -receptor antagonist 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 (S…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022275

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022275
Product	Strength	Form · route	Labeler	Product NDC
Samscatolvaptan	Tolvaptan 30 mg/1	TabletOral	Otsuka America Pharmaceutical, Inc.	59148-021