Over-the-counter drug · ANDA
Motrin PM (Ibuprofen and diphenhydramine citrate) NDC 50580-563
Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 · Tablet, Coated · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-563-20 | 5058005632050580056320 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Jan 11, 2010 | |
| 50580-563-80 | 5058005638050580056380 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Jan 11, 2010 |
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 PMSuffix: PM
- Generic name (nonproprietary)
- ibuprofen and diphenhydramine citrate
- Active ingredients
- Ibuprofen — 200 mg/1Diphenhydramine citrate — 38 mg/1
- Dosage form
- Tablet, Coated
- 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 079113
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50580-563_39a34ab2-9fae-444e-e063-6294a90a9152SPL ID 39a34ab2-9fae-444e-e063-6294a90a9152SPL set ID 55403f19-58ae-450b-8a7b-0bc544088f20RxCUI 895664, 895666UNII WK2XYI10QM, 4OD433S209UPC 0300450563804
- Pharmacologic class
- Histamine-1 Receptor Antagonist; 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
N450580056320followed by a unit qualifier and the quantityPackage 50580-0563-20. 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 for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Excerpt only. Read the full label for complete information.
About NDC 50580-563
- What is NDC 50580-563?
- 50580-563 is the product NDC for Motrin PM, Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 tablet, coated, 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?
- Motrin PM (Ibuprofen and Diphenhydramine Citrate).
- What is the active ingredient?
- Ibuprofen, Diphenhydramine citrate.
- 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 Motrin PM?
- 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 079113
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 ibuprofen pmdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-050 |
| Care One Ibuprofen PMdiphenhydramine citrate and ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-050 |
| dg health Ibuprofen pmdiphenhydramine citrate and ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-050 |
| equaline ibuprofen pmdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-050 |
| equate ibuprofen pmdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores Inc | 49035-699 |
| Exchange Select Ibuprofen PMdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Army & Air Force Exchange Service | 55301-050 |
| foster and thrive ibuprofen pmdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services LLC | 70677-1131 |
| good neighbor pharmacy ibuprofen pmdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Amerisource Bergen | 46122-708 |
| good sense ibuprofen pmdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0050 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-0050 |
| ibuprofen pmdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-0050 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Safeway | 21130-623 |
| ibuprofen pmdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Kroger Company | 30142-050 |
| ibuprofen pmdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | H E B | 37808-703 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-050 |
| ibuprofen pmdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-050 |
| ibuprofen pmdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Publix Super Markets Inc | 56062-050 |
| ibuprofen pmdiphenhydramine citrate and ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-050 |
| Leader Ibuprofen PMdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0157 |
| Topcare Ibuprofen PMdiphenhydramine citrate and ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-050 |
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