Prescription drug · NDA
Butrans (Buprenorphine) NDC 59011-758
Buprenorphine 15 ug/h · Patch, Extended release · Transdermal · Knoa Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59011-758-04 | 5901107580459011075804 | 4 POUCH in 1 CARTON (59011-758-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCHMarketed from Feb 14, 2011 |
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)
- Butrans
- Generic name (nonproprietary)
- buprenorphine
- Active ingredients
- Buprenorphine — 15 ug/h
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Knoa Pharma LLCNDC labeler code 59011
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021306
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 59011-758_cf5d162f-a313-4f27-a292-3ecf640fbea7SPL ID cf5d162f-a313-4f27-a292-3ecf640fbea7SPL set ID 794aa355-66de-41b8-aedf-f2c40f6bc664RxCUI 904870, 904874, 904876, 904878, 904880, 904882, 1432969, 1432971, 1542997, 1542999UNII 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
N459011075804followed by a unit qualifier and the quantityPackage 59011-0758-04. 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)
BUTRANS 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 BUTRANS, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. BUTRANS is not indicated as an as-needed (prn) analgesic. BUTRANS is a p…
Excerpt only. Read the full label for complete information.
About NDC 59011-758
- What is NDC 59011-758?
- 59011-758 is the product NDC for Butrans (buprenorphine), Buprenorphine 15 ug/h patch, extended release, listed with the FDA by Knoa Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Butrans (Buprenorphine).
- What is the active ingredient?
- Buprenorphine.
- Who is the labeler?
- Knoa Pharma LLC, NDC labeler code 59011. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Butrans?
- 4 other product NDCs are listed under this name. See all Butrans NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Butrans products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Butransbuprenorphine | Buprenorphine 5 ug/h | Patch, Extended releaseTransdermal | Knoa Pharma LLC | 59011-750 | 59011-0750-04 |
| Butransbuprenorphine | Buprenorphine 10 ug/h | Patch, Extended releaseTransdermal | Knoa Pharma LLC | 59011-751 | 59011-0751-04 |
| Butransbuprenorphine | Buprenorphine 20 ug/h | Patch, Extended releaseTransdermal | Knoa Pharma LLC | 59011-752 | 59011-0752-04 |
| Butransbuprenorphine | Buprenorphine 7.5 ug/h | Patch, Extended releaseTransdermal | Knoa Pharma LLC | 59011-757 | 59011-0757-04 |
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 |
|---|---|---|---|---|
| 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 |
| Buprenorphine | Buprenorphine 20 ug/h | PatchTransdermal | Rhodes Pharmaceuticals LLC | 42858-839 |
| 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 20 ug/h | Patch, Extended releaseTransdermal | Knoa Pharma LLC | 59011-752 |
| Butransbuprenorphine | Buprenorphine 7.5 ug/h | Patch, Extended releaseTransdermal | Knoa Pharma LLC | 59011-757 |