Prescription drug · ANDA
Buprenorphine NDC 50742-375
Buprenorphine 15 ug/h · Patch, Extended release · Transdermal · INGENUS PHARMACEUTICALS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-375-04 | 5074203750450742037504 | 4 POUCH in 1 CARTON (50742-375-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCHMarketed from Nov 1, 2023 |
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 — 15 ug/h
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- INGENUS PHARMACEUTICALS, LLCNDC labeler code 50742
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210272
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 50742-375_5090c42d-8c7d-a0b9-e063-6294a90a925dSPL ID 5090c42d-8c7d-a0b9-e063-6294a90a925dSPL set ID 186e3be6-8bc0-4bb9-96f5-429d53632f45RxCUI 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
N450742037504followed by a unit qualifier and the quantityPackage 50742-0375-04. 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 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 transde…
Excerpt only. Read the full label for complete information.
About NDC 50742-375
- What is NDC 50742-375?
- 50742-375 is the product NDC for Buprenorphine, Buprenorphine 15 ug/h patch, extended release, listed with the FDA by INGENUS PHARMACEUTICALS, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Buprenorphine.
- What is the active ingredient?
- Buprenorphine.
- Who is the labeler?
- INGENUS PHARMACEUTICALS, LLC, NDC labeler code 50742. 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?
- 53 other product NDCs are listed under this name. See all Buprenorphine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Buprenorphine 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 | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Unit Dose Solutions, Inc. | 87441-082 | 87441-0082-01 |
| Buprenorphine | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Unit Dose Solutions, Inc. | 87441-011 | 87441-0011-01 |
| Buprenorphine | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | AvPAK | 50268-128 | 50268-0128-15 |
| Buprenorphine | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | AvPAK | 50268-129 | 50268-0129-15 |
| Buprenorphine | Buprenorphine 5 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1521 | 03215-1521-04 |
| Buprenorphine | Buprenorphine 7.5 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1522 | 03215-1522-04 |
| Buprenorphine | Buprenorphine 10 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1523 | 03215-1523-04 |
| Buprenorphine | Buprenorphine 15 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1524 | 03215-1524-04 |
| Buprenorphine | Buprenorphine 20 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1525 | 03215-1525-04 |
| Buprenorphine | Buprenorphine 5 ug/h | Patch, Extended releaseTransdermal | INGENUS PHARMACEUTICALS, LLC | 50742-372 | 50742-0372-04 |
Other NDCs under ANDA 210272
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 5 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1521 |
| Buprenorphine | Buprenorphine 7.5 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1522 |
| Buprenorphine | Buprenorphine 10 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1523 |
| Buprenorphine | Buprenorphine 15 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1524 |
| Buprenorphine | Buprenorphine 20 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-1525 |
| Buprenorphine | Buprenorphine 5 ug/h | Patch, Extended releaseTransdermal | INGENUS PHARMACEUTICALS, LLC | 50742-372 |
| Buprenorphine | Buprenorphine 7.5 ug/h | Patch, Extended releaseTransdermal | INGENUS PHARMACEUTICALS, LLC | 50742-373 |
| Buprenorphine | Buprenorphine 10 ug/h | Patch, Extended releaseTransdermal | INGENUS PHARMACEUTICALS, LLC | 50742-374 |
| Buprenorphine | Buprenorphine 20 ug/h | Patch, Extended releaseTransdermal | INGENUS PHARMACEUTICALS, LLC | 50742-376 |