Fentanyl NDC 50742-553

NDC codes

FDA NDC Directory

Product NDC (as listed)50742-553Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50742-0553Add 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
50742-553-05	50742055305	5 POUCH in 1 CARTON (50742-553-05) / 1 PATCH in 1 POUCH (50742-553-01) / 72 h in 1 PATCHMarketed from Feb 10, 2025

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
Generic name (nonproprietary): fentanyl
Active ingredients: Fentanyl — 62.5 ug/h
Dosage form: Patch, Extended release
Route: Transdermal
Labeler: INGENUS PHARMACEUTICALS, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077449
Marketing start: Feb 10, 2025
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 50742-553_4edfd739-fc61-0f08-e063-6394a90ae646SPL ID 4edfd739-fc61-0f08-e063-6394a90ae646SPL set ID bf02ffd0-cc5d-446b-b648-378f6885052fRxCUI 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

N450742055305 followed by a unit qualifier and the quantity

Package 50742-0553-05. 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 7, 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 dosa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077449

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

FDA NDC Directory listings under ANDA 077449
Product	Strength	Form · route	Labeler	Product NDC
Fentanyl	Fentanyl 25 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-550
Fentanyl	Fentanyl 12 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-549
Fentanyl	Fentanyl 75 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-554
Fentanyl	Fentanyl 37.5 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-551
Fentanyl	Fentanyl 50 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-552
Fentanyl	Fentanyl 87.5 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-555
Fentanyl	Fentanyl 100 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-556
Fentanyl	Fentanyl 37.5 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-7703
Fentanyl	Fentanyl 12 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-7701
Fentanyl	Fentanyl 25 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-7702
Fentanyl	Fentanyl 75 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-7706
Fentanyl	Fentanyl 50 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-7704
Fentanyl	Fentanyl 62.5 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-7705
Fentanyl	Fentanyl 87.5 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-7707
Fentanyl	Fentanyl 100 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-7708