Prescription drug · ANDA
Fentanyl NDC 0378-9127
Fentanyl 87.5 ug/h · Patch · Transdermal · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-9127-98 | 0037891279800378912798 | 5 POUCH in 1 CARTON (0378-9127-98) / 1 PATCH in 1 POUCH (0378-9127-16) / 72 h in 1 PATCHMarketed from Feb 26, 2015 |
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
- Generic name (nonproprietary)
- fentanyl
- Active ingredients
- Fentanyl — 87.5 ug/h
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076258
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0378-9127_a6e21c86-57e5-4be5-b1bb-c894893991b2SPL ID a6e21c86-57e5-4be5-b1bb-c894893991b2SPL set ID 2a2238e9-4b5d-c56d-8663-dd354ff9ae0cRxCUI 197696, 245134, 245135, 245136, 577057, 1603495, 1603498, 1603501UNII 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
N400378912798followed by a unit qualifier and the quantityPackage 00378-9127-98. 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 do…
Excerpt only. Read the full label for complete information.
About NDC 0378-9127
- What is NDC 0378-9127?
- 0378-9127 is the product NDC for Fentanyl, Fentanyl 87.5 ug/h patch, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fentanyl.
- What is the active ingredient?
- Fentanyl.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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?
- 23 other product NDCs are listed under this name. See all Fentanyl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fentanyl 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 | Fentanyl 87.5 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-7707 | 03215-7707-05 |
| Fentanyl | Fentanyl 87.5 ug/h | Patch, Extended releaseTransdermal | INGENUS PHARMACEUTICALS, LLC | 50742-555 | 50742-0555-05 |
| Fentanyl | Fentanyl 62.5 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-7705 | 03215-7705-05 |
| Fentanyl | Fentanyl 62.5 ug/h | Patch, Extended releaseTransdermal | INGENUS PHARMACEUTICALS, LLC | 50742-553 | 50742-0553-05 |
| Fentanyl | Fentanyl 37.5 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-7703 | 03215-7703-05 |
| Fentanyl | Fentanyl 37.5 ug/h | Patch, Extended releaseTransdermal | INGENUS PHARMACEUTICALS, LLC | 50742-551 | 50742-0551-05 |
| Fentanyl | Fentanyl 12 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-7701 | 03215-7701-05 |
| Fentanyl | Fentanyl 12 ug/h | Patch, Extended releaseTransdermal | INGENUS PHARMACEUTICALS, LLC | 50742-549 | 50742-0549-05 |
| Fentanyl | Fentanyl 25 ug/h | Patch, Extended releaseTransdermal | Aveva Drug Delivery Systems Inc. | 3215-7702 | 03215-7702-05 |
| Fentanyl | Fentanyl 25 ug/h | Patch, Extended releaseTransdermal | INGENUS PHARMACEUTICALS, LLC | 50742-550 | 50742-0550-05 |
Other NDCs under ANDA 076258
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 | Fentanyl 12 ug/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-9119 |
| Fentanyl | Fentanyl 25 ug/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-9121 |
| Fentanyl | Fentanyl 50 ug/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-9122 |
| Fentanyl | Fentanyl 75 ug/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-9123 |
| Fentanyl | Fentanyl 100 ug/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-9124 |
| Fentanyl | Fentanyl 37.5 ug/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-9125 |
| Fentanyl | Fentanyl 62.5 ug/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-9126 |