Prescription drug · ANDA
Buprenorphine and Naloxone NDC 72162-1347
Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 · Tablet · Sublingual · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1347-3 | 72162134703 | 30 TABLET in 1 BOTTLE, PLASTIC (72162-1347-3)Marketed from Apr 3, 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 and Naloxone
- Generic name (nonproprietary)
- buprenorphine and naloxone
- Active ingredients
- Buprenorphine hydrochloride — 8 mg/1Naloxone hydrochloride dihydrate — 2 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 205601
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72162-1347_d563927d-0972-45e0-b179-14692a4f1b7aSPL ID d563927d-0972-45e0-b179-14692a4f1b7aSPL set ID fe023dbf-e165-4b7f-a211-bd14696f1e2cRxCUI 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
N472162134703followed by a unit qualifier and the quantityPackage 72162-1347-03. 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 .
Indications (excerpt from the label)
Buprenorphine and naloxone sublingual tablets are indicated for 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.
Other NDCs under ANDA 205601
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | 72162-1346 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Unit Dose Solutions, Inc. | 87441-001 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Redpharm Drug | 67296-2164 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | American Health Packaging | 60687-626 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | American Health Packaging | 60687-637 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-3389 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-2981 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | 63629-9482 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Rhodes Pharmaceuticals LLC | 42858-601 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Bryant Ranch Prepack | 63629-9483 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Rhodes Pharmaceuticals LLC | 42858-602 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-2828 |