Over-the-counter drug · ANDA
Diclofenac Sodium NDC 57483-185
Diclofenac sodium 10 mg/g · Gel · Topical · INNOVUS PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57483-185-11 | 57483018511 | 1 TUBE in 1 CARTON (57483-185-11) / 150 g in 1 TUBE (57483-185-01)Marketed from Mar 25, 2025 |
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)
- Diclofenac Sodium
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204306
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 57483-185_ad9d2c28-21bc-4f81-9c90-cce6a96d976aSPL ID ad9d2c28-21bc-4f81-9c90-cce6a96d976aSPL set ID ad9d2c28-21bc-4f81-9c90-cce6a96d976aRxCUI 855633UNII 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
N457483018511followed by a unit qualifier and the quantityPackage 57483-0185-11. 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.
Other NDCs under ANDA 204306
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 |
|---|---|---|---|---|
| Amazon Basic Care Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Amazon.com Services LLC | 72288-624 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Harris Teeter | 72036-014 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Aurobindo Pharma Limited | 84386-120 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Aurohealth LLC | 58602-604 |
| Diclofenac Sodium | — | Kit | Aurohealth LLC | 58602-606 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Aurohealth LLC | 58602-609 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | KROGER COMPANY | 30142-277 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Redpharm Drug | 67296-2155 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Sportpharm LLC | 85766-137 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | GERI-CARE PHARMACEUTICAL CORP | 57896-147 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4135 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4335 |