Over-the-counter drug · ANDA

Tylenol 8 Hr Arthritis Pain (Acetaminophen) NDC 50580-575

Acetaminophen 650 mg/1 · Tablet, Film coated, Extended release · Oral · Kenvue Brands LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)50580-575Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0575Add 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 NDC11-digit (billing)PackageCopy
50580-575-01505800575011 BOTTLE in 1 CARTON (50580-575-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Jan 30, 2024
50580-575-02505800575021 BOTTLE in 1 CARTON (50580-575-02) / 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Jan 30, 2024
50580-575-03505800575031 BOTTLE in 1 CARTON (50580-575-03) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Jan 30, 2024
50580-575-06505800575061 BOTTLE in 1 CARTON (50580-575-06) / 225 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 Arthritis 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
Listing expires
Identifiers
Product ID 50580-575_21acf19d-d04f-97ca-e063-6294a90a5e41SPL ID 21acf19d-d04f-97ca-e063-6294a90a5e41SPL set ID 0391963c-022d-1433-e063-6294a90aac90RxCUI 1148399, 1243440UNII 362O9ITL9DUPC 0300450838216

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

N450580057501 followed by a unit qualifier and the quantity

Package 50580-0575-01. 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 .

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50580-575

What is NDC 50580-575?
50580-575 is the product NDC for Tylenol 8 Hr Arthritis Pain (acetaminophen), Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Kenvue Brands LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tylenol 8 Hr Arthritis 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 Arthritis Pain?
1 other product NDC are listed under this name. See all Tylenol 8 Hr Arthritis Pain NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tylenol 8 Hr Arthritis Pain NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tylenol 8 HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralKenvue Brands LLC50580-78350580-0783-1050580-0783-2450580-0783-25+4 more

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
ProductStrengthForm · routeLabelerProduct NDC
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-629
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralVALU MERCHANDISERS COMPANY63941-300
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARC GLASSMAN, INC.68998-401
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-083
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-630
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-679
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralVALU MERCHANDISERS COMPANY63941-401
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC70677-1123
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-082
8 HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDr. Reddy's Laboratories Inc.75907-430
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHARRIS TEETER72036-200
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralFSA STORE INC.81522-200
8HR Muscle Aches and PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-201
8HR Muscle Aches and PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralFSA STORE INC.81522-201
AcetaminophenAcetaminophen 650 mg/1TabletOralWalgreens0363-0892
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALGREENS0363-9992
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALGREENS CO.0363-9993
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8624
AcetaminophenAcetaminophen 650 mg/1TabletOralMAJOR PHARMACEUTICALS0904-7314
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-5019

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