BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE NDC 58118-0549

NDC codes

FDA NDC Directory

Product NDC (as listed)58118-0549Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58118-0549Add 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
58118-0549-8	58118054908	30 TABLET in 1 BLISTER PACK (58118-0549-8)Marketed from Mar 5, 2026

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 HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
Generic name (nonproprietary): buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Active ingredients: Buprenorphine hydrochloride — 2 mg/1Naloxone hydrochloride dihydrate — .5 mg/1
Dosage form: Tablet
Route: Sublingual
Labeler: Clinical Solutions Wholesale, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209069
Marketing start: Sep 1, 2020
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 58118-0549_4c4c5192-a558-7b5f-e063-6394a90a43a6SPL ID 4c4c5192-a558-7b5f-e063-6394a90a43a6SPL set ID 8f2b94dc-f42f-45d5-8274-9e748ec20ef0RxCUI 351266UNII 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

N458118054908 followed by a unit qualifier and the quantity

Package 58118-0549-08. 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 Mar 5, 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 are indicated for the maintenance treatment of opioid dependence. (1) Buprenorphine and naloxone sublingual tablets should be used as a 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 209069

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

FDA NDC Directory listings under ANDA 209069
Product	Strength	Form · route	Labeler	Product NDC
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Bryant Ranch Prepack	71335-1858
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Redpharm Drug	67296-2191
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1	TabletSublingual	Accord Healthcare, Inc	16729-549
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Accord Healthcare, Inc	16729-550
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Asclemed USA, Inc.	76420-534