Prescription drug · ANDA
Buprenorphine And Naloxone NDC 67877-607
Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 · Tablet · Sublingual · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-607-30 | 67877060730 | 30 TABLET in 1 BOTTLE (67877-607-30)Marketed from Jul 3, 2026 | |
| 67877-607-84 | 67877060784 | 3 BLISTER PACK in 1 CARTON (67877-607-84) / 10 TABLET in 1 BLISTER PACKMarketed from Jul 3, 2026 | |
| 67877-607-90 | 67877060790 | 90 TABLET in 1 BOTTLE (67877-607-90)Marketed from Jul 3, 2026 |
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 — 2 mg/1Naloxone hydrochloride — .5 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214930
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 67877-607_f06091b6-2823-40db-bf86-e56a86db4532SPL ID f06091b6-2823-40db-bf86-e56a86db4532SPL set ID 2e807ed0-6df3-47b5-b7ee-b421c5bf0aa7RxCUI 351266, 351267UNII 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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N467877060730followed by a unit qualifier and the quantityPackage 67877-0607-30. 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 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 to include 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 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 214930
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 | TabletSublingual | Ascend Laboratories, LLC | 67877-606 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.