Over-the-counter drug · ANDA
Motrin Dual Action With Tylenol NDC 50580-208
acetaminophen and ibuprofen · Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 · Tablet, Film coated · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-208-02 | 50580020802 | 1 BOTTLE in 1 CARTON (50580-208-02) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 20, 2023 | |
| 50580-208-08 | 50580020808 | 1 BOTTLE in 1 CARTON (50580-208-08) / 80 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 20, 2023 | |
| 50580-208-12 | 50580020812 | 1 BOTTLE in 1 CARTON (50580-208-12) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 20, 2023 | |
| 50580-208-16 | 50580020816 | 2 CARTON in 1 CARTON (50580-208-16) / 1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 1, 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)
- Motrin Dual Action With Tylenol
- Generic name (nonproprietary)
- acetaminophen and ibuprofen
- Active ingredients
- Ibuprofen — 125 mg/1Acetaminophen — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Kenvue Brands LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214836
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 50580-208_48d075d6-52f3-6fd7-e063-6394a90ada71SPL ID 48d075d6-52f3-6fd7-e063-6394a90ada71SPL set ID f2ee9cf5-02b7-6612-e053-2995a90a90c4RxCUI 2387532UNII WK2XYI10QM, 362O9ITL9DUPC 0300450311207
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N450580020802followed by a unit qualifier and the quantityPackage 50580-0208-02. 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: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214836
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 |
|---|---|---|---|---|
| Basic Care Dual Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-530 |
| Leader Dual Action Pain Relieveracetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0737 |
| Pain Relieveracetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 69842-675 |
| dual pain relieveracetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Meijer, Inc. | 79481-0503 |
| equate dual pain relieveracetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-243 |
| Dual Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-542 |
| foster and thrive dual actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services LLC | 70677-1274 |
| acetaminophen and ibuprofenacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Kroger Company | 30142-720 |
| DG health dual pain relieveracetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-441 |
| Dual Back Pain Relieveracetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-6199 |
| Dual Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-540 |
| equate dual back pain relieveracetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-326 |
| Careone Dual Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Retail Business Services, LLC | 72476-231 |
| dg health dual back pain relieveracetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-508 |
| good sense dual actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-044 |
| equaline dual action pain relieveracetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-103 |
| topcare dual actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 76162-501 |
| Topcare Dual Action Back Painacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 76162-520 |
| dual actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-5777 |
| dual pain relieveracetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-5220 |
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