Prescription drug · ANDA
Fentanyl Transdermal NDC 0406-9100
Fentanyl 100 ug/h · Patch, Extended release · Transdermal · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-9100-76 | 00406910076 | 5 POUCH in 1 CARTON (0406-9100-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCHMarketed from May 6, 2020 |
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)
- Fentanyl Transdermal
- Generic name (nonproprietary)
- fentanyl transdermal
- Active ingredients
- Fentanyl — 100 ug/h
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- SpecGx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077154
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0406-9100_35cb1ff2-8cbf-40cc-8e71-4040b0bdb64eSPL ID 35cb1ff2-8cbf-40cc-8e71-4040b0bdb64eSPL set ID e15a7e9b-8025-49dd-9a6d-bafcccf1959fRxCUI 197696, 245134, 245135, 245136, 577057, 1603495, 1603498UNII 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
N400406910076followed by a unit qualifier and the quantityPackage 00406-9100-76. 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 dosage…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077154
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 Transdermal | Fentanyl 37.5 ug/h | Patch, Extended releaseTransdermal | SpecGx LLC | 0406-9037 |
| Fentanyl Transdermal | Fentanyl 62.5 ug/h | Patch, Extended releaseTransdermal | SpecGx LLC | 0406-9062 |
| Fentanyl Transdermal | Fentanyl 12.5 ug/h | Patch, Extended releaseTransdermal | SpecGx LLC | 0406-9112 |
| Fentanyl Transdermal | Fentanyl 25 ug/h | Patch, Extended releaseTransdermal | SpecGx LLC | 0406-9125 |
| Fentanyl Transdermal | Fentanyl 50 ug/h | Patch, Extended releaseTransdermal | SpecGx LLC | 0406-9150 |
| Fentanyl Transdermal | Fentanyl 75 ug/h | Patch, Extended releaseTransdermal | SpecGx LLC | 0406-9175 |