Prescription drug · ANDA
Buprenorphine and Naloxone NDC 50742-365
Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1 · Film · Buccal, Sublingual · INGENUS PHARMACEUTICALS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-365-30 | 50742036530 | 30 POUCH in 1 CARTON (50742-365-30) / 1 FILM in 1 POUCH (50742-365-01)Marketed from Aug 29, 2023 |
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 and Naloxone
- Generic name (nonproprietary)
- buprenorphine and naloxone
- Active ingredients
- Buprenorphine hydrochloride — 12 mg/1Naloxone hydrochloride — 3 mg/1
- Dosage form
- Film
- Route
- Buccal, Sublingual
- Labeler
- INGENUS PHARMACEUTICALS, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212756
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 50742-365_4db0df39-ce1f-bb08-e063-6294a90a3a4aSPL ID 4db0df39-ce1f-bb08-e063-6294a90a3a4aSPL set ID 4951ec29-609b-4836-b0e4-0d9c1d6ae6feRxCUI 1010600, 1010604, 1307056, 1307061UNII 56W8MW3EN1, F850569PQR
- 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. Buccal, Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450742036530followed by a unit qualifier and the quantityPackage 50742-0365-30. 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 film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual film contains buprenorphine, a partial-opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual film 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 212756
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 8 mg/1; Naloxone hydrochloride 2 mg/1 | FilmBuccal, Sublingual | INGENUS PHARMACEUTICALS, LLC | 50742-364 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1 | FilmBuccal, Sublingual | INGENUS PHARMACEUTICALS, LLC | 50742-398 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 | FilmBuccal, Sublingual | INGENUS PHARMACEUTICALS, LLC | 50742-397 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 | FilmBuccal, Sublingual | Redpharm Drug | 67296-2228 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1 | FilmBuccal, Sublingual | Aveva Drug Delivery Systems Inc. | 3215-6523 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 | FilmBuccal, Sublingual | Aveva Drug Delivery Systems Inc. | 3215-6521 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1 | FilmBuccal, Sublingual | Aveva Drug Delivery Systems Inc. | 3215-6522 |
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1 | FilmBuccal, Sublingual | Aveva Drug Delivery Systems Inc. | 3215-6524 |