What is NDC 60505-4317?

60505-4317 is the product NDC for tolvaptan, Tolvaptan 15 mg/1 tablet, listed with the FDA by Apotex Corp.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for tolvaptan?

41 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

tolvaptan NDC 60505-4317 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-4317Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-4317Add 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
60505-4317-0	6050543170060505431700	1 BLISTER PACK in 1 CARTON (60505-4317-0) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 14, 2022
60505-4317-3	6050543170360505431703	30 TABLET in 1 BOTTLE (60505-4317-3)Marketed from Dec 14, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Apotex Corp.NDC labeler code 60505
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207605
Marketing start: Dec 14, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Vasopressin V2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 60505-4317_f0a587b3-af44-097a-8e8a-8cfd15676e33SPL ID f0a587b3-af44-097a-8e8a-8cfd15676e33
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

N460505431700 followed by a unit qualifier and the quantity

Package 60505-4317-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60505-4317

What is NDC 60505-4317?: 60505-4317 is the product NDC for tolvaptan, Tolvaptan 15 mg/1 tablet, listed with the FDA by Apotex Corp.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: tolvaptan.
What is the active ingredient?: Tolvaptan.
Who is the labeler?: Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for tolvaptan?: 41 other product NDCs are listed under this name. See all tolvaptan NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other tolvaptan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tolvaptan	Tolvaptan 15 mg/1	TabletOral	Ascend Laboratories, LLC	67877-915	67877-0915-30
Tolvaptan	Tolvaptan 30 mg/1	TabletOral	Ascend Laboratories, LLC	67877-916	67877-0916-30
Tolvaptan	Tolvaptan 45 mg/1	TabletOral	Ascend Laboratories, LLC	67877-917	67877-0917-30
Tolvaptan	Tolvaptan 60 mg/1	TabletOral	Ascend Laboratories, LLC	67877-918	67877-0918-30
Tolvaptan	Tolvaptan 90 mg/1	TabletOral	Ascend Laboratories, LLC	67877-919	67877-0919-30
Tolvaptan	—	Kit	Ascend Laboratories, LLC	67877-920	67877-0920-54
Tolvaptan	—	Kit	Ascend Laboratories, LLC	67877-921	67877-0921-54
Tolvaptan	—	Kit	Ascend Laboratories, LLC	67877-922	67877-0922-54
Tolvaptan	—	Kit	Ascend Laboratories, LLC	67877-923	67877-0923-54
Tolvaptan	—	Kit	Ascend Laboratories, LLC	67877-924	67877-0924-54

All 42 tolvaptan NDCs

Other NDCs under ANDA 207605

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

FDA NDC Directory listings under ANDA 207605
Product	Strength	Form · route	Labeler	Product NDC
tolvaptan	Tolvaptan 30 mg/1	TabletOral	Apotex Corp.	60505-4318