Fentanyl Transdermal NDC 0406-9112

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-9112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-9112Add 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
0406-9112-76	00406911276	5 POUCH in 1 CARTON (0406-9112-76) / 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 — 12.5 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: May 6, 2020
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0406-9112_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

N400406911276 followed by a unit qualifier and the quantity

Package 00406-9112-76. 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 Apr 30, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077154

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

FDA NDC Directory listings under ANDA 077154
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 100 ug/h	Patch, Extended releaseTransdermal	SpecGx LLC	0406-9100
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