What is NDC 50580-576?

50580-576 is the product NDC for Tylenol 8 Hr Muscle Aches And Pain, 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 8 Hr Muscle Aches And Pain (Acetaminophen).

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 8 Hr Muscle Aches And Pain?

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 8 Hr Muscle Aches And Pain NDC 50580-576

NDC codes

FDA NDC Directory

Product NDC (as listed)50580-576Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50580-0576Add 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
50580-576-01	5058005760150580057601	1 BOTTLE in 1 CARTON (50580-576-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Jan 30, 2024
50580-576-02	5058005760250580057602	1 BOTTLE in 1 CARTON (50580-576-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Jan 30, 2024

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 8 Hr Muscle Aches And Pain
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: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start: Jan 30, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 50580-576_21acd9d2-84aa-3a95-e063-6394a90af438SPL ID 21acd9d2-84aa-3a95-e063-6394a90af438SPL set ID 037ec598-cba6-dbb6-e063-6394a90ac42cRxCUI 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

N450580057601 followed by a unit qualifier and the quantity

Package 50580-0576-01. 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 50580-576

What is NDC 50580-576?: 50580-576 is the product NDC for Tylenol 8 Hr Muscle Aches And Pain, 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 8 Hr Muscle Aches And Pain (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 8 Hr Muscle Aches And Pain?: 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 ANDA 211544

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

FDA NDC Directory listings under ANDA 211544
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	CHAIN DRUG MARKETING ASSOCIATION INC	63868-660
8 Hour Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	MARC GLASSMAN, INC.	68998-401
Acetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8624
8 Hour Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	STRATEGIC SOURCING SERVICES LLC	70677-1123
8 Hour Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	AMERISOURCE BERGEN	46122-629
8 Hour Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	AMERISOURCE BERGEN	46122-630
8 Hour Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	VALU MERCHANDISERS COMPANY	63941-401
Acetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Granules USA, Inc.	69848-015
arthritis pain reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	Meijer	41250-658
Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	AMERIFOODS TRADING COMPANY	61504-200
Tylenol 8 Hr Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Kenvue Brands LLC	50580-575
Arthritis Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	WINCO FOODS, LLC	67091-401
Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	DISCOUNT DRUG MART	53943-200
8 Hour Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	CHAIN DRUG MARKETING ASSOCIATION INC	63868-679
8HR Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	HARRIS TEETER	72036-200
Acetaminophen	Acetaminophen 650 mg/1	TabletOral	FAMILY DOLLAR	55319-185
Acetaminophen Extended-Releaseacetaminophen	Acetaminophen 650 mg/1	TabletOral	Magno-Humphries, Inc.	54257-573
Acetaminophen	Acetaminophen 650 mg/1	TabletOral	WAL-MART STORES INC	79903-137
Acetaminophen	Acetaminophen 650 mg/1	TabletOral	MAJOR PHARMACEUTICALS	0904-7314
Acetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	GERI-CARE PHARMACEUTICAL CORP	57896-268

Showing 20 of 39.

Tylenol 8 Hr Muscle Aches And Pain (Acetaminophen) NDC 50580-576