Prescription drug · ANDA
Diclofenac Sodium 1.5% (Diclofenac sodium topical) NDC 85509-1038
Diclofenac sodium 16.05 mg/mL · Solution · Topical · PHOENIX RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85509-1038-1 | 8550910380185509103801 | 1 BOTTLE in 1 CARTON (85509-1038-1) / 150 mL in 1 BOTTLEMarketed from Aug 1, 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)
- Diclofenac Sodium 1.5%
- Generic name (nonproprietary)
- diclofenac sodium topical
- Active ingredients
- Diclofenac sodium — 16.05 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- PHOENIX RX LLCNDC labeler code 85509
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204132
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 85509-1038_43d20f29-5ad0-d36b-e063-6294a90afd32SPL ID 43d20f29-5ad0-d36b-e063-6294a90afd32SPL set ID 3b40a448-3f5e-fe6f-e063-6394a90a32dfRxCUI 857700UNII QTG126297Q
- 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
N485509103801followed by a unit qualifier and the quantityPackage 85509-1038-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).
Excerpt only. Read the full label for complete information.
About NDC 85509-1038
- What is NDC 85509-1038?
- 85509-1038 is the product NDC for Diclofenac Sodium 1.5% (diclofenac sodium topical), Diclofenac sodium 16.05 mg/mL solution, listed with the FDA by PHOENIX RX LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Sodium 1.5% (Diclofenac Sodium Topical).
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- PHOENIX RX LLC, NDC labeler code 85509. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diclofenac Sodium 1.5%?
- 3 other product NDCs are listed under this name. See all Diclofenac Sodium 1.5% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diclofenac Sodium 1.5% products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-8084 | — |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | SOLA Pharmaceuticals | 70512-038 | 70512-0038-05 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Proficient Rx LP | 71205-640 | 71205-0640-15 |
Other NDCs under ANDA 204132
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 |
|---|---|---|---|---|
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | Solution/ dropsTransdermal | Proficient Rx LP | 63187-791 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | DIRECT RX | 72189-273 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | Solution/ dropsTransdermal | Asclemed USA, Inc. | 76420-134 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Advanced Rx of Tennessee, LLC | 80425-0240 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-8084 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | SOLA Pharmaceuticals | 70512-038 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Proficient Rx LP | 71205-640 |