Sudafed PE Head Congestion Plus Pain NDC 50580-436

NDC codes

FDA NDC Directory

Product NDC (as listed)50580-436Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50580-0436Add 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
50580-436-01	50580043601	2 BLISTER PACK in 1 CARTON (50580-436-01) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 17, 2019

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): Sudafed PE Head Congestion Plus Pain
Generic name (nonproprietary): ibuprofen and phenylephrine hydrochloride
Active ingredients: Ibuprofen — 200 mg/1Phenylephrine hydrochloride — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Kenvue Brands LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203200
Marketing start: Jun 17, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 50580-436_2ffbcc44-0ef3-b149-e063-6394a90ae7f5SPL ID 2ffbcc44-0ef3-b149-e063-6394a90ae7f5SPL set ID 76513fb2-7323-4f1f-8a10-92f8f603cf97RxCUI 1369775UNII WK2XYI10QM, 04JA59TNSJUPC 0300450551207
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug; alpha-1 Adrenergic 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450580043601 followed by a unit qualifier and the quantity

Package 50580-0436-01. 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 10, 2025.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains reduces swelling of the nasal passages temporarily restores freer breathing through the nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203200

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

FDA NDC Directory listings under ANDA 203200
Product	Strength	Form · route	Labeler	Product NDC
Congestion Reliefibuprofen, phenylephrine hcl	Ibuprofen 200 mg/1; Phenylephrine hydrochloride 10 mg/1	Tablet, Film coatedOral	Meijer Distribution Inc	41250-158
Equaline congestion reliefibuprofen, phenylephrine hcl	Ibuprofen 200 mg/1; Phenylephrine hydrochloride 10 mg/1	Tablet, Film coatedOral	United Natural Foods, Inc. dba UNFI	41163-158