Over-the-counter drug · ANDA
Motrin Arthritis Pain (Diclofenac sodium) NDC 50580-574
Diclofenac sodium 9.3 mg/g · Gel · Topical · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-574-01 | 5058005740150580057401 | 1 TUBE in 1 CARTON (50580-574-01) / 50 g in 1 TUBEMarketed from Jun 20, 2022 | |
| 50580-574-02 | 5058005740250580057402 | 1 TUBE in 1 CARTON (50580-574-02) / 100 g in 1 TUBEMarketed from Jun 20, 2022 |
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 Arthritis Pain
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 9.3 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Kenvue Brands LLCNDC labeler code 50580
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211253
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 50580-574_21aceda5-2c35-23df-e063-6394a90acb09SPL ID 21aceda5-2c35-23df-e063-6394a90acb09SPL set ID db5b4288-13ec-826b-e053-2995a90a275eUNII QTG126297QUPC 0300450574039
- 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450580057401followed by a unit qualifier and the quantityPackage 50580-0574-01. 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 for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.
Excerpt only. Read the full label for complete information.
About NDC 50580-574
- What is NDC 50580-574?
- 50580-574 is the product NDC for Motrin Arthritis Pain (diclofenac sodium), Diclofenac sodium 9.3 mg/g gel, 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 Arthritis Pain (Diclofenac sodium).
- What is the active ingredient?
- Diclofenac sodium.
- 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 Arthritis Pain?
- 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 211253
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 |
|---|---|---|---|---|
| good sense arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | A-S Medication Solutions | 50090-7250 |
| arthritis pain relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Walgreen Company | 0363-5123 |
| arthritis pain relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Meijer Distribution Inc | 41250-674 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-3456 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Publix Super Markets Inc | 56062-471 |
| Equate Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | WALMART INC. | 79903-391 |
| Arthritis Pain Reliefdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-517 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-953 |
| topcare athritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Topco Associates LLC | 36800-526 |
| CareOne arthritis pain reliefdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | American Sales Company | 41520-788 |
| arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Publix Super Markets Inc | 56062-878 |
| Aspercreme Arthritisdiclofenac sodium | Diclofenac sodium .01 g/g | GelTopical | Chattem, Inc. | 41167-0573 |
| Arthritis Pain Relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Walgreen Company | 0363-3003 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS Pharmacy | 69842-729 |
| good sense arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | L. Perrigo Company | 0113-1189 |
| basic care arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Amazon.com Services LLC | 72288-870 |
| berkley and jensen arthritis paindiclofenac sodium | — | Kit | BJWC | 68391-205 |
| Members Mark Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Sam's West Inc | 68196-523 |
| Dg Health Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Dolgencorp Inc | 55910-926 |
| members mark arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Sam's West Inc | 68196-870 |
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