Prescription drug · ANDA
Buprenorphine NDC 0093-3657
Buprenorphine 10 ug/h · Patch, Extended release · Transdermal · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-3657-40 | 00093365740 | 4 POUCH in 1 CARTON (0093-3657-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCHMarketed from Nov 26, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 ug/h
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204937
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0093-3657_606ac164-7172-49b9-b72f-2efb545dcbb2SPL ID 606ac164-7172-49b9-b72f-2efb545dcbb2SPL set ID 36995ce3-b515-447b-baa9-aa14f84060d8RxCUI 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
N400093365740followed by a unit qualifier and the quantityPackage 00093-3657-40. 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. L imitations 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 204937
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 | Patch, Extended releaseTransdermal | Teva Pharmaceuticals USA, Inc. | 0093-3239 |
| Buprenorphine | Buprenorphine 5 ug/h | Patch, Extended releaseTransdermal | Teva Pharmaceuticals USA, Inc. | 0093-3656 |
| Buprenorphine | Buprenorphine 15 ug/h | Patch, Extended releaseTransdermal | Teva Pharmaceuticals USA, Inc. | 0093-3658 |
| Buprenorphine | Buprenorphine 20 ug/h | Patch, Extended releaseTransdermal | Teva Pharmaceuticals USA, Inc. | 0093-3659 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.