Buprenorphine HCl and Naloxone HCl NDC 65162-416

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-416Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0416Add 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
65162-416-03	65162041603	30 TABLET in 1 BOTTLE (65162-416-03)Marketed from Feb 22, 2013
65162-416-09	65162041609	90 TABLET in 1 BOTTLE (65162-416-09)Marketed from Feb 22, 2013

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 HCl and Naloxone HCl
Generic name (nonproprietary): buprenorphine and naloxone
Active ingredients: Buprenorphine hydrochloride — 2 mg/1Naloxone hydrochloride dihydrate — .5 mg/1
Dosage form: Tablet
Route: Sublingual
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203136
Marketing start: Feb 22, 2013
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 65162-416_4cea862f-8edf-4035-a7f5-328beff51a29SPL ID 4cea862f-8edf-4035-a7f5-328beff51a29SPL set ID 17b63f10-c9df-44be-80fa-6f1c305583b8RxCUI 351266, 351267UNII 56W8MW3EN1, 5Q187997EE
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

N465162041603 followed by a unit qualifier and the quantity

Package 65162-0416-03. 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 Feb 2, 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 Tablets contain 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 203136

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

FDA NDC Directory listings under ANDA 203136
Product	Strength	Form · route	Labeler	Product NDC
Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1	TabletSublingual	Bryant Ranch Prepack	71335-1514
Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Bryant Ranch Prepack	63629-5074
Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1	TabletSublingual	AvPAK	50268-144
Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	AvPAK	50268-145
Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1	TabletSublingual	Bryant Ranch Prepack	63629-7269
Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Amneal Pharmaceuticals LLC	65162-415