Prescription drug · ANDA
buprenorphine transdermal system (Buprenorphine) NDC 58064-408
Buprenorphine 20 ug/h · Patch, Extended release · Transdermal · LTS Therapy Systems, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58064-408-04 | 5806404080458064040804 | 4 POUCH in 1 CARTON (58064-408-04) / 1 PATCH in 1 POUCH (58064-408-11) / 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 — 20 ug/h
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- LTS Therapy Systems, LLCNDC labeler code 58064
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207490
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 58064-408_45afa585-2243-cf7b-e063-6394a90a74e1SPL ID 45afa585-2243-cf7b-e063-6394a90a74e1
- 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
N458064040804followed by a unit qualifier and the quantityPackage 58064-0408-04. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 58064-408
- What is NDC 58064-408?
- 58064-408 is the product NDC for buprenorphine transdermal system (buprenorphine), Buprenorphine 20 ug/h patch, extended release, listed with the FDA by LTS Therapy Systems, LLC. 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?
- LTS Therapy Systems, LLC, NDC labeler code 58064. 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 10 ug/h | Patch, Extended releaseTransdermal | Alvogen Inc. | 47781-407 | 47781-0407-04 |
| 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 |
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 10 ug/h | Patch, Extended releaseTransdermal | Alvogen Inc. | 47781-407 |
| 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 |