Tolvaptan NDC 70748-238

NDC codes

FDA NDC Directory

Product NDC (as listed)70748-238Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70748-0238Add 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
70748-238-06	70748023806	30 TABLET in 1 BOTTLE (70748-238-06)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
Active ingredients: Tolvaptan — 15 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216063
Marketing start: May 12, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Vasopressin V2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 70748-238_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
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

N470748023806 followed by a unit qualifier and the quantity

Package 70748-0238-06. 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 9, 2025. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216063

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

FDA NDC Directory listings under ANDA 216063
Product	Strength	Form · route	Labeler	Product NDC
Tolvaptan	—	Kit	Lupin Pharmaceuticals, Inc.	70748-240
Tolvaptan	Tolvaptan 30 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	70748-239
Tolvaptan	—	Kit	Lupin Pharmaceuticals, Inc.	70748-243
Tolvaptan	—	Kit	Lupin Pharmaceuticals, Inc.	70748-241
Tolvaptan	—	Kit	Lupin Pharmaceuticals, Inc.	70748-242
Tolvaptan	—	Kit	Lupin Pharmaceuticals, Inc.	70748-244