Over-the-counter drug · NDA
Tylenol 8 HR Arthritis Pain (Acetaminophen) NDC 50580-783
Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-783-10 | 50580078310 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-10) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Jul 13, 2015 | |
| 50580-783-24 | 50580078324 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-24) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Jul 13, 2015 | |
| 50580-783-25 | 50580078325 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-25) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Jul 13, 2015 | |
| 50580-783-30 | 50580078330 | 290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50580-783-30)Marketed from Feb 12, 2018 | |
| 50580-783-31 | 50580078331 | 1 BOTTLE in 1 CARTON (50580-783-31) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jun 1, 2022 | |
| 50580-783-32 | 50580078332 | 1 BOTTLE in 1 CARTON (50580-783-32) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Aug 26, 2019 | |
| 50580-783-51 | 50580078351 | 50 POUCH in 1 CARTON (50580-783-51) / 2 TABLET, EXTENDED RELEASE in 1 POUCHMarketed from Nov 22, 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, 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
- Listing expires
- Identifiers
- Product ID 50580-783_26c62e88-08c4-1113-e063-6394a90ac1f8SPL ID 26c62e88-08c4-1113-e063-6394a90ac1f8SPL set ID 3af22fc8-e4e0-4863-8696-6bc1257047cbRxCUI 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
N450580078310followed by a unit qualifier and the quantityPackage 50580-0783-10. 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.
About NDC 50580-783
- What is NDC 50580-783?
- 50580-783 is the product NDC for Tylenol 8 HR Arthritis Pain (acetaminophen), Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by Kenvue Brands LLC. It has 7 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.
Related NDCs: other Tylenol 8 HR Arthritis Pain products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tylenol 8 Hr Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Kenvue Brands LLC | 50580-575 | 50580-0575-0150580-0575-0250580-0575-03+1 more |
Other NDCs under NDA 019872
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tylenol 8HRacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Kenvue Brands LLC | 50580-309 |