Prescription drug · NDA AUTHORIZED GENERIC
Buprenorphine NDC 42858-839
Buprenorphine 20 ug/h · Patch · Transdermal · Rhodes Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42858-839-40 | 42858083940 | 4 POUCH in 1 CARTON (42858-839-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCHMarketed from Jul 5, 2017 |
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
- Generic name (nonproprietary)
- buprenorphine
- Active ingredients
- Buprenorphine — 20 ug/h
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Rhodes Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021306
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 42858-839_424dfded-f6e0-4640-a8d4-bd4bf75b138bSPL ID 424dfded-f6e0-4640-a8d4-bd4bf75b138bSPL set ID 2738feae-316e-426f-971c-5f142ac01b60RxCUI 904870, 904876, 904880, 1432969, 1542997UNII 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
N442858083940followed by a unit qualifier and the quantityPackage 42858-0839-40. 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 opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Buprenorphine transder…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021306
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 |
|---|---|---|---|---|
| Butransbuprenorphine | Buprenorphine 20 ug/h | Patch, Extended releaseTransdermal | Knoa Pharma LLC | 59011-752 |
| Butransbuprenorphine | Buprenorphine 5 ug/h | Patch, Extended releaseTransdermal | Knoa Pharma LLC | 59011-750 |
| Butransbuprenorphine | Buprenorphine 10 ug/h | Patch, Extended releaseTransdermal | Knoa Pharma LLC | 59011-751 |
| Butransbuprenorphine | Buprenorphine 7.5 ug/h | Patch, Extended releaseTransdermal | Knoa Pharma LLC | 59011-757 |
| Butransbuprenorphine | Buprenorphine 15 ug/h | Patch, Extended releaseTransdermal | Knoa Pharma LLC | 59011-758 |
| Buprenorphine | Buprenorphine 7.5 ug/h | PatchTransdermal | Rhodes Pharmaceuticals LLC | 42858-353 |
| Buprenorphine | Buprenorphine 10 ug/h | PatchTransdermal | Rhodes Pharmaceuticals LLC | 42858-493 |
| Buprenorphine | Buprenorphine 15 ug/h | PatchTransdermal | Rhodes Pharmaceuticals LLC | 42858-586 |
| Buprenorphine | Buprenorphine 5 ug/h | PatchTransdermal | Rhodes Pharmaceuticals LLC | 42858-750 |