Prescription drug · UNAPPROVED DRUG OTHER
Xiclofen (Diclofenac sodium, methyl salicylate) NDC 83295-5050
Diclofenac sodium .01 g/g; Methyl salicylate .05 g/g · Ointment · Cutaneous · STRAND HEALTH GROUP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83295-5050-1 | 8329550500183295505001 | 1 TUBE in 1 BOX (83295-5050-1) / 85 g in 1 TUBEMarketed from Feb 7, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Xiclofen
- Generic name (nonproprietary)
- diclofenac sodium, methyl salicylate
- Active ingredients
- Diclofenac sodium — .01 g/gMethyl salicylate — .05 g/g
- Dosage form
- Ointment
- Route
- Cutaneous
- Labeler
- STRAND HEALTH GROUPNDC labeler code 83295
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 83295-5050_35a73eb0-39ac-30d4-e063-6294a90a97d6SPL ID 35a73eb0-39ac-30d4-e063-6294a90a97d6SPL set ID 2d92d378-2e9c-f9d5-e063-6294a90ac715RxCUI 2704846UNII QTG126297Q, LAV5U5022Y
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N483295505001followed by a unit qualifier and the quantityPackage 83295-5050-01. 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)
1. INDICATIONS & USAGE Xiclofen TM Ointment is indicated in adults over the age of 12 years old for the treatment of signs and symptoms of osteoarthritis of the joints, and of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.
Excerpt only. Read the full label for complete information.
About NDC 83295-5050
- What is NDC 83295-5050?
- 83295-5050 is the product NDC for Xiclofen, Diclofenac sodium .01 g/g; Methyl salicylate .05 g/g ointment, listed with the FDA by STRAND HEALTH GROUP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xiclofen (Diclofenac sodium, methyl salicylate).
- What is the active ingredient?
- Diclofenac sodium, Methyl salicylate.
- Who is the labeler?
- STRAND HEALTH GROUP, NDC labeler code 83295. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xiclofen?
- 1 other product NDC are listed under this name. See all Xiclofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xiclofen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xiclofendiclofenac sodium, methyl salicylate | Diclofenac sodium .01 g/g; Methyl salicylate .05 g/g | OintmentCutaneous | ASCLEMED USA INC. | 87063-056 | 87063-0056-85 |