TYLENOL 8 HR ARTHRITIS PAIN
- Product NDC
- 50580-575
- 11-digit product format
- 505800575
- Labeler code
- 50580
- Product ID
- 50580-575_21acf19d-d04f-97ca-e063-6294a90a5e41
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- ANDA211544
- Marketing category
- ANDA
- Marketing start
- 2024-01-30
- Substance
- ACETAMINOPHEN
- Active strength
- 650 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50580-575-01 | 50580057501 | 1 BOTTLE in 1 CARTON (50580-575-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2024-01-30 | No | No | Historical |
| 50580-575-02 | 50580057502 | 1 BOTTLE in 1 CARTON (50580-575-02) / 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2024-01-30 | No | No | Historical |
| 50580-575-03 | 50580057503 | 1 BOTTLE in 1 CARTON (50580-575-03) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2024-01-30 | No | No | Historical |
| 50580-575-06 | 50580057506 | 1 BOTTLE in 1 CARTON (50580-575-06) / 225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2024-01-30 | No | No | Historical |