Prescription drug · ANDA
Buprenorphine HCl and Naloxone HCl (Buprenorphine and naloxone) NDC 65162-415
Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 · Tablet · Sublingual · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-415-03 | 6516204150365162041503 | 30 TABLET in 1 BOTTLE (65162-415-03)Marketed from Feb 22, 2013 | |
| 65162-415-09 | 6516204150965162041509 | 90 TABLET in 1 BOTTLE (65162-415-09)Marketed from Feb 22, 2013 |
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 HCl and Naloxone HCl
- Generic name (nonproprietary)
- buprenorphine and naloxone
- Active ingredients
- Buprenorphine hydrochloride — 8 mg/1Naloxone hydrochloride dihydrate — 2 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203136
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 65162-415_4cea862f-8edf-4035-a7f5-328beff51a29SPL ID 4cea862f-8edf-4035-a7f5-328beff51a29SPL set ID 17b63f10-c9df-44be-80fa-6f1c305583b8RxCUI 351266, 351267UNII 5Q187997EE, 56W8MW3EN1
- 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
N465162041503followed by a unit qualifier and the quantityPackage 65162-0415-03. 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 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 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.
About NDC 65162-415
- What is NDC 65162-415?
- 65162-415 is the product NDC for Buprenorphine HCl and Naloxone HCl, Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Buprenorphine HCl and Naloxone HCl (Buprenorphine and Naloxone).
- What is the active ingredient?
- Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Buprenorphine HCl and Naloxone HCl?
- 6 other product NDCs are listed under this name. See all Buprenorphine HCl and Naloxone HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Buprenorphine HCl and Naloxone HCl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | AvPAK | 50268-144 | 50268-0144-15 |
| Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | AvPAK | 50268-145 | 50268-0145-15 |
| Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Bryant Ranch Prepack | 63629-5074 | 63629-5074-0063629-5074-0163629-5074-02+7 more |
| Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | 63629-7269 | 63629-7269-01 |
| Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Amneal Pharmaceuticals LLC | 65162-416 | 65162-0416-0365162-0416-09 |
| Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-1514 | 71335-1514-0171335-1514-02 |
Other NDCs under ANDA 203136
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 HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | AvPAK | 50268-144 |
| Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | AvPAK | 50268-145 |
| Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Bryant Ranch Prepack | 63629-5074 |
| Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | 63629-7269 |
| Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Amneal Pharmaceuticals LLC | 65162-416 |
| Buprenorphine HCl and Naloxone HClbuprenorphine and naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-1514 |