What is NDC 67877-637?

67877-637 is the product NDC for Tolvaptan, Tolvaptan 60 mg/1 tablet, listed with the FDA by Ascend Laboratories, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Ascend Laboratories, LLC, NDC labeler code 67877. 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 67877-637 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67877-637Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67877-0637Add 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
67877-637-01	6787706370167877063701	100 TABLET in 1 BOTTLE (67877-637-01)Marketed from May 21, 2020
67877-637-02	6787706370267877063702	10 TABLET in 1 BOTTLE (67877-637-02)Marketed from May 21, 2020
67877-637-33	6787706373367877063733	1 BLISTER PACK in 1 CARTON (67877-637-33) / 10 TABLET in 1 BLISTER PACKMarketed from May 21, 2020

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 — 60 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Ascend Laboratories, LLCNDC labeler code 67877
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211891
Marketing start: May 21, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Vasopressin V2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 67877-637_f75355a8-50ef-4a88-aaa0-c85c0ae5c23dSPL ID f75355a8-50ef-4a88-aaa0-c85c0ae5c23dSPL set ID dd71ee70-9435-4715-bee5-edbb5a8d7d7bRxCUI 849827, 849833, 2044363UNII 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

N467877063701 followed by a unit qualifier and the quantity

Package 67877-0637-01. 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 Sep 7, 2022. 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 is a selective vasopressin V2-receptor a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67877-637

What is NDC 67877-637?: 67877-637 is the product NDC for Tolvaptan, Tolvaptan 60 mg/1 tablet, listed with the FDA by Ascend Laboratories, LLC. It has 3 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?: Ascend Laboratories, LLC, NDC labeler code 67877. 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 211891

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

FDA NDC Directory listings under ANDA 211891
Product	Strength	Form · route	Labeler	Product NDC
Tolvaptan	Tolvaptan 15 mg/1	TabletOral	Ascend Laboratories, LLC	67877-635
Tolvaptan	Tolvaptan 30 mg/1	TabletOral	Ascend Laboratories, LLC	67877-636