Buprenorphine and Naloxone NDC 31722-850

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-850Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0850Add 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
31722-850-30	31722085030	30 TABLET in 1 BOTTLE (31722-850-30)Marketed from Jan 5, 2026

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): Buprenorphine and Naloxone
Generic name (nonproprietary): buprenorphine and naloxone
Active ingredients: Buprenorphine hydrochloride — 2 mg/1Naloxone hydrochloride dihydrate — .5 mg/1
Dosage form: Tablet
Route: Sublingual
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219727
Marketing start: Jan 5, 2026
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 31722-850_60f89242-ae36-4fe3-bd5c-8f34effd6534SPL ID 60f89242-ae36-4fe3-bd5c-8f34effd6534SPL set ID 5ab2d4e4-3c8c-413a-b147-23eafbde313aRxCUI 351266, 351267UNII 56W8MW3EN1, 5Q187997EEUPC 0331722850308, 0331722851305
Pharmacologic class: Opioid Antagonist; Partial Opioid Agonist

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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N431722085030 followed by a unit qualifier and the quantity

Package 31722-0850-30. 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 Jan 28, 2026.

Indications (excerpt from the label)

Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine and naloxone sublingual tablets contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. (1) Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 219727

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

FDA NDC Directory listings under ANDA 219727
Product	Strength	Form · route	Labeler	Product NDC
Buprenorphine and Naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Camber Pharmaceuticals, Inc.	31722-851