Fentanyl NDC 0378-9127

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-9127Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-9127Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0378-9127-98	00378912798	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.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076258
Marketing start: Feb 26, 2015
Listing expires: Dec 31, 2027
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

N400378912798 followed by a unit qualifier and the quantity

Package 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 Dec 15, 2025. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076258

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076258
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