Fentanyl system (fentanyl) NDC 47781-428

NDC codes

FDA NDC Directory

Product NDC (as listed)47781-428Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47781-0428Add 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
47781-428-47	47781042847	5 POUCH in 1 CARTON (47781-428-47) / 1 PATCH in 1 POUCH (47781-428-11)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 — 100 ug/1
Dosage form: Patch
Route: Transdermal
Labeler: ALVOGEN
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202097
Marketing start: Nov 4, 2016
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 47781-428_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

N447781042847 followed by a unit qualifier and the quantity

Package 47781-0428-47. 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 Mar 2, 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 dosag…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202097

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

FDA NDC Directory listings under ANDA 202097
Product	Strength	Form · route	Labeler	Product NDC
Fentanyl systemfentanyl	Fentanyl 25 ug/1	PatchTransdermal	ALVOGEN	47781-424
Fentanyl systemfentanyl	Fentanyl 12.5 ug/1	PatchTransdermal	ALVOGEN	47781-423
Fentanyl systemfentanyl	Fentanyl 50 ug/1	PatchTransdermal	ALVOGEN	47781-426
Fentanyl systemfentanyl	Fentanyl 75 ug/1	PatchTransdermal	ALVOGEN	47781-427