Buprenorphine and Naloxone NDC 71335-1296

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1296Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1296Add 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
71335-1296-1	71335129601	30 TABLET in 1 BOTTLE (71335-1296-1)Marketed from Aug 12, 2019
71335-1296-2	71335129602	10 TABLET in 1 BOTTLE (71335-1296-2)Marketed from May 17, 2024

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): Buprenorphine and Naloxone
Generic name (nonproprietary): buprenorphine and naloxone
Active ingredients: Buprenorphine — 2 mg/1Naloxone — .5 mg/1
Dosage form: Tablet
Route: Sublingual
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205022
Marketing start: Sep 19, 2016
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 71335-1296_b01e74e4-7e26-446f-a533-86db53d4ae79SPL ID b01e74e4-7e26-446f-a533-86db53d4ae79SPL set ID fc2755a5-3292-4b49-872d-e22c386a4e44RxCUI 351266UNII 40D3SCR4GZ, 36B82AMQ7N
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

N471335129601 followed by a unit qualifier and the quantity

Package 71335-1296-01. 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 Jun 11, 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 that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual tablet 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 tablet 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 205022

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

FDA NDC Directory listings under ANDA 205022
Product	Strength	Form · route	Labeler	Product NDC
Buprenorphine and Naloxone	Buprenorphine 8 mg/1; Naloxone 2 mg/1	TabletSublingual	Bryant Ranch Prepack	71335-1378
Buprenorphine and Naloxone	Buprenorphine 2 mg/1; Naloxone .5 mg/1	TabletSublingual	Lannett Company, Inc.	62175-452
Buprenorphine and Naloxone	Buprenorphine 8 mg/1; Naloxone 2 mg/1	TabletSublingual	Lannett Company, Inc.	62175-458