What is NDC 50580-309?

50580-309 is the product NDC for Tylenol 8HR (acetaminophen), Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Kenvue Brands LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tylenol 8HR?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tylenol 8HR NDC 50580-309 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50580-309Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50580-0309Add 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
50580-309-01	50580030901	1 BOTTLE in 1 CARTON (50580-309-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Jan 18, 2016
50580-309-02	50580030902	1 BOTTLE in 1 CARTON (50580-309-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Jan 18, 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): Tylenol 8HR
Generic name (nonproprietary): acetaminophen
Active ingredients: Acetaminophen — 650 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Kenvue Brands LLCNDC labeler code 50580
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019872
Marketing start: Jan 18, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 50580-309_21e84490-8cad-bf34-e063-6394a90af940SPL ID 21e84490-8cad-bf34-e063-6394a90af940SPL set ID 5d7d1300-bcb8-466a-880b-310b360ee132RxCUI 1148399, 1243440UNII 362O9ITL9DUPC 0300450297211

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

N450580030901 followed by a unit qualifier and the quantity

Package 50580-0309-01. 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 Nov 7, 2024.

Indications (excerpt from the label)

Uses temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50580-309

What is NDC 50580-309?: 50580-309 is the product NDC for Tylenol 8HR (acetaminophen), Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Kenvue Brands LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tylenol 8HR (Acetaminophen).
What is the active ingredient?: Acetaminophen.
Who is the labeler?: Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tylenol 8HR?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 019872

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

FDA NDC Directory listings under NDA 019872
Product	Strength	Form · route	Labeler	Product NDC
Tylenol 8 HR Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	Kenvue Brands LLC	50580-783

Tylenol 8HR (Acetaminophen) NDC 50580-309