What is NDC 31722-868?

31722-868 is the product NDC for Tolvaptan, Tolvaptan 15 mg/1 tablet, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 31722-868 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-868Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0868Add 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
31722-868-01	3172208680131722086801	10 BLISTER PACK in 1 CARTON (31722-868-01) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 6, 2022
31722-868-02	3172208680231722086802	10 BLISTER PACK in 1 CARTON (31722-868-02) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 6, 2022
31722-868-03	3172208680331722086803	1 BLISTER PACK in 1 CARTON (31722-868-03) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 6, 2022
31722-868-04	3172208680431722086804	1 BLISTER PACK in 1 CARTON (31722-868-04) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 6, 2022

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: Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205646
Marketing start: Sep 6, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Vasopressin V2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 31722-868_e7e86fa1-8352-5245-e053-2995a90a70f6SPL ID e7e86fa1-8352-5245-e053-2995a90a70f6SPL set ID 6f4c5679-8490-45ec-bd34-1a569e3af850RxCUI 849827, 849833UNII 21G72T1950UPC 0331722869034
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

N431722086801 followed by a unit qualifier and the quantity

Package 31722-0868-01. 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 5, 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 provide a symptomatic benefit to patients. Tolvaptan tablets are a selective vasopressin V 2 -recepto…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-868

What is NDC 31722-868?: 31722-868 is the product NDC for Tolvaptan, Tolvaptan 15 mg/1 tablet, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 4 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?: Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 205646

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

FDA NDC Directory listings under ANDA 205646
Product	Strength	Form · route	Labeler	Product NDC
Tolvaptan	Tolvaptan 30 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-869