Prescription drug · ANDA
Buprenorphine and Naloxone NDC 71335-1378
Buprenorphine 8 mg/1; Naloxone 2 mg/1 · Tablet · Sublingual · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1378-0 | 71335137800 | 42 TABLET in 1 BOTTLE (71335-1378-0)Marketed from May 20, 2024 | |
| 71335-1378-1 | 71335137801 | 30 TABLET in 1 BOTTLE (71335-1378-1)Marketed from Oct 25, 2019 | |
| 71335-1378-2 | 71335137802 | 60 TABLET in 1 BOTTLE (71335-1378-2)Marketed from May 20, 2024 | |
| 71335-1378-3 | 71335137803 | 90 TABLET in 1 BOTTLE (71335-1378-3)Marketed from May 20, 2024 | |
| 71335-1378-4 | 71335137804 | 120 TABLET in 1 BOTTLE (71335-1378-4)Marketed from May 20, 2024 | |
| 71335-1378-5 | 71335137805 | 14 TABLET in 1 BOTTLE (71335-1378-5)Marketed from May 20, 2024 | |
| 71335-1378-6 | 71335137806 | 28 TABLET in 1 BOTTLE (71335-1378-6)Marketed from May 20, 2024 | |
| 71335-1378-7 | 71335137807 | 6 TABLET in 1 BOTTLE (71335-1378-7)Marketed from May 20, 2024 | |
| 71335-1378-8 | 71335137808 | 10 TABLET in 1 BOTTLE (71335-1378-8)Marketed from May 20, 2024 | |
| 71335-1378-9 | 71335137809 | 21 TABLET in 1 BOTTLE (71335-1378-9)Marketed from May 20, 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 — 8 mg/1Naloxone — 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 205022
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 71335-1378_8c128665-a43f-41ae-a67e-068f840618f5SPL ID 8c128665-a43f-41ae-a67e-068f840618f5SPL set ID 2063d5bf-b3bc-4e73-9046-7e994446ab50RxCUI 351267UNII 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
N471335137800followed by a unit qualifier and the quantityPackage 71335-1378-00. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 205022
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 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 |
| Buprenorphine and Naloxone | Buprenorphine 2 mg/1; Naloxone .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-1296 |