Prescription drug · ANDA
Buprenorphine and Naloxone Sublingual Film (Buprenorphine and naloxone) NDC 47781-355
Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 · Film · Buccal, Sublingual · Alvogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47781-355-03 | 4778103550347781035503 | 30 POUCH in 1 CARTON (47781-355-03) / 1 FILM in 1 POUCH (47781-355-11)Marketed from Feb 11, 2019 |
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 Sublingual FilmSuffix: Sublingual Film
- Generic name (nonproprietary)
- buprenorphine and naloxone
- Active ingredients
- Buprenorphine hydrochloride — 2 mg/1Naloxone hydrochloride dihydrate — .5 mg/1
- Dosage form
- Film
- Route
- Buccal, Sublingual
- Labeler
- Alvogen Inc.NDC labeler code 47781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205954
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 47781-355_cf48e146-c279-72ae-6437-005aeea86e46SPL ID cf48e146-c279-72ae-6437-005aeea86e46SPL set ID 4210afeb-474c-d842-d68e-af7e0021851aRxCUI 1010600, 1010604, 1307056, 1307061UNII 5Q187997EE, 56W8MW3EN1UPC 0347781356118, 0347781358037, 0347781355036, 0347781357030, 0347781356033, 0347781358112, 0347781357115, 0347781355111
- 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
N447781035503followed by a unit qualifier and the quantityPackage 47781-0355-03. 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 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.
About NDC 47781-355
- What is NDC 47781-355?
- 47781-355 is the product NDC for Buprenorphine and Naloxone Sublingual Film, Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 film, listed with the FDA by Alvogen Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Buprenorphine and Naloxone Sublingual Film (Buprenorphine and Naloxone).
- What is the active ingredient?
- Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate.
- Who is the labeler?
- Alvogen Inc., NDC labeler code 47781. 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 and Naloxone Sublingual Film?
- 4 other product NDCs are listed under this name. See all Buprenorphine and Naloxone Sublingual Film NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Buprenorphine and Naloxone Sublingual Film 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 and Naloxone Sublingual Filmbuprenorphine and naloxone | Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride dihydrate 1 mg/1 | FilmBuccal, Sublingual | Alvogen Inc. | 47781-356 | 47781-0356-03 |
| Buprenorphine and Naloxone Sublingual Filmbuprenorphine and naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | FilmBuccal, Sublingual | Alvogen Inc. | 47781-357 | 47781-0357-03 |
| Buprenorphine and Naloxone Sublingual Filmbuprenorphine and naloxone | Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride dihydrate 3 mg/1 | FilmBuccal, Sublingual | Alvogen Inc. | 47781-358 | 47781-0358-03 |
| Buprenorphine and Naloxone Sublingual Filmbuprenorphine and naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | FilmBuccal, Sublingual | Redpharm Drug | 67296-1933 | 67296-1933-06 |
Other NDCs under ANDA 205954
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 Sublingual Filmbuprenorphine and naloxone | Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride dihydrate 1 mg/1 | FilmBuccal, Sublingual | Alvogen Inc. | 47781-356 |
| Buprenorphine and Naloxone Sublingual Filmbuprenorphine and naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | FilmBuccal, Sublingual | Alvogen Inc. | 47781-357 |
| Buprenorphine and Naloxone Sublingual Filmbuprenorphine and naloxone | Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride dihydrate 3 mg/1 | FilmBuccal, Sublingual | Alvogen Inc. | 47781-358 |
| Buprenorphine and Naloxone Sublingual Filmbuprenorphine and naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | FilmBuccal, Sublingual | Redpharm Drug | 67296-1933 |