Prescription drug · ANDA
buprenorphine transdermal system (Buprenorphine) NDC 47781-407
Buprenorphine 10 ug/h · Patch, Extended release · Transdermal · Alvogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47781-407-04 | 4778104070447781040704 | 4 POUCH in 1 CARTON (47781-407-04) / 1 PATCH in 1 POUCH (47781-407-11) / 168 h in 1 PATCHMarketed from Aug 29, 2022 |
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 transdermal system
- Generic name (nonproprietary)
- buprenorphine
- Active ingredients
- Buprenorphine — 10 ug/h
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Alvogen Inc.NDC labeler code 47781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207490
- Marketing start
- Marketing end
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 47781-407_7f83c8aa-7590-e2fe-4998-55323eadd112SPL ID 7f83c8aa-7590-e2fe-4998-55323eadd112SPL set ID 315284b8-32ab-d34a-ea02-f501c6131bccRxCUI 904870, 904876, 904880, 1432969UNII 40D3SCR4GZ
- Pharmacologic class
- 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N447781040704followed by a unit qualifier and the quantityPackage 47781-0407-04. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse and misuse with opioids, which can occur at any dosage or duration, and because of the greater risk of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions ( 5.1 )] , reserve buprenorphine transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or w…
Excerpt only. Read the full label for complete information.
About NDC 47781-407
- What is NDC 47781-407?
- 47781-407 is the product NDC for buprenorphine transdermal system (buprenorphine), Buprenorphine 10 ug/h patch, extended release, 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 transdermal system (Buprenorphine).
- What is the active ingredient?
- Buprenorphine.
- 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 transdermal system?
- 4 other product NDCs are listed under this name. See all buprenorphine transdermal system NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other buprenorphine transdermal system 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 transdermal systembuprenorphine | Buprenorphine 5 ug/h | Patch, Extended releaseTransdermal | Alvogen Inc. | 47781-406 | 47781-0406-04 |
| buprenorphine transdermal systembuprenorphine | Buprenorphine 20 ug/h | Patch, Extended releaseTransdermal | Alvogen Inc. | 47781-408 | 47781-0408-04 |
| buprenorphine transdermal systembuprenorphine | Buprenorphine 15 ug/h | Patch, Extended releaseTransdermal | Alvogen Inc. | 47781-419 | 47781-0419-04 |
| buprenorphine transdermal systembuprenorphine | Buprenorphine 20 ug/h | Patch, Extended releaseTransdermal | LTS Therapy Systems, LLC | 58064-408 | 58064-0408-04 |
Other NDCs under ANDA 207490
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 transdermal systembuprenorphine | Buprenorphine 5 ug/h | Patch, Extended releaseTransdermal | Alvogen Inc. | 47781-406 |
| buprenorphine transdermal systembuprenorphine | Buprenorphine 20 ug/h | Patch, Extended releaseTransdermal | Alvogen Inc. | 47781-408 |
| buprenorphine transdermal systembuprenorphine | Buprenorphine 15 ug/h | Patch, Extended releaseTransdermal | Alvogen Inc. | 47781-419 |
| buprenorphine transdermal systembuprenorphine | Buprenorphine 20 ug/h | Patch, Extended releaseTransdermal | LTS Therapy Systems, LLC | 58064-408 |