Prescription drug · ANDA
Fentanyl system (Fentanyl) NDC 47781-427
Fentanyl 75 ug/1 · Patch · Transdermal · ALVOGEN
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47781-427-47 | 4778104274747781042747 | 5 POUCH in 1 CARTON (47781-427-47) / 1 PATCH in 1 POUCH (47781-427-11)Marketed from Nov 4, 2016 |
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)
- Fentanyl system
- Generic name (nonproprietary)
- fentanyl
- Active ingredients
- Fentanyl — 75 ug/1
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- ALVOGENNDC labeler code 47781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202097
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 47781-427_4b8493ea-0ce4-6949-e063-6294a90a8861SPL ID 4b8493ea-0ce4-6949-e063-6294a90a8861SPL set ID 242759ef-cb6d-4e3e-9f8d-5e31efa1f289RxCUI 197696, 245134, 245135, 245136, 577057UNII UF599785JZ
- Pharmacologic class
- 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
N447781042747followed by a unit qualifier and the quantityPackage 47781-0427-47. 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)
Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosag…
Excerpt only. Read the full label for complete information.
About NDC 47781-427
- What is NDC 47781-427?
- 47781-427 is the product NDC for Fentanyl system (fentanyl), Fentanyl 75 ug/1 patch, listed with the FDA by ALVOGEN. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fentanyl system (Fentanyl).
- What is the active ingredient?
- Fentanyl.
- Who is the labeler?
- ALVOGEN, NDC labeler code 47781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fentanyl system?
- 4 other product NDCs are listed under this name. See all Fentanyl system NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fentanyl 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) |
|---|---|---|---|---|---|
| Fentanyl systemfentanyl | Fentanyl 12.5 ug/1 | PatchTransdermal | ALVOGEN | 47781-423 | 47781-0423-47 |
| Fentanyl systemfentanyl | Fentanyl 25 ug/1 | PatchTransdermal | ALVOGEN | 47781-424 | 47781-0424-47 |
| Fentanyl systemfentanyl | Fentanyl 50 ug/1 | PatchTransdermal | ALVOGEN | 47781-426 | 47781-0426-47 |
| Fentanyl systemfentanyl | Fentanyl 100 ug/1 | PatchTransdermal | ALVOGEN | 47781-428 | 47781-0428-47 |
Other NDCs under ANDA 202097
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 |
|---|---|---|---|---|
| Fentanyl systemfentanyl | Fentanyl 12.5 ug/1 | PatchTransdermal | ALVOGEN | 47781-423 |
| Fentanyl systemfentanyl | Fentanyl 25 ug/1 | PatchTransdermal | ALVOGEN | 47781-424 |
| Fentanyl systemfentanyl | Fentanyl 50 ug/1 | PatchTransdermal | ALVOGEN | 47781-426 |
| Fentanyl systemfentanyl | Fentanyl 100 ug/1 | PatchTransdermal | ALVOGEN | 47781-428 |