Prescription drug · ANDA
Buprenorphine NDC 69238-1204
Buprenorphine 15 ug/h · Patch, Extended release · Transdermal · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1204-2 | 69238120402 | 4 POUCH in 1 CARTON (69238-1204-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCHMarketed from Apr 20, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211586
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 69238-1204_5b776a17-f8cd-413d-934b-fcbe0de7f8d4SPL ID 5b776a17-f8cd-413d-934b-fcbe0de7f8d4SPL set ID c7d079fb-507f-436f-b794-2171b7d97067RxCUI 904870, 904876, 904880, 1432969, 1542997UNII 40D3SCR4GZUPC 0369238120325, 0369238120226, 0369238120523, 0369238150520, 0369238120424
- 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
N469238120402followed by a unit qualifier and the quantityPackage 69238-1204-02. 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 ANDA 211586
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 20 ug/h | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1205 |
| Buprenorphine | Buprenorphine 5 ug/h | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1202 |
| Buprenorphine | Buprenorphine 10 ug/h | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1203 |
| Buprenorphine | Buprenorphine 7.5 ug/h | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1505 |