Prescription drug · ANDA
Diclofenac Sodium NDC 80425-0361
Diclofenac sodium 16.05 mg/mL · Solution · Topical · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0361-1 | 80425036101 | 1 BOTTLE, DROPPER in 1 CARTON (80425-0361-1) / 150 mL in 1 BOTTLE, DROPPERMarketed from Oct 18, 2023 |
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
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 16.05 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203818
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 80425-0361_2a998d83-7baf-3f5e-e063-6294a90acd3dSPL ID 2a998d83-7baf-3f5e-e063-6294a90acd3dSPL set ID 0803345d-7811-bc21-e063-6394a90aa661RxCUI 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
N480425036101followed by a unit qualifier and the quantityPackage 80425-0361-01. 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 topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203818
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 | SolutionTopical | REMEDYREPACK INC. | 70518-2811 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Asclemed USA, Inc. | 76420-919 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | A-S Medication Solutions | 50090-6713 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Sun Pharmaceutical Industries, Inc. | 51672-1358 |
| Diclofenac sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Proficient Rx LP | 71205-062 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Direct_Rx | 72189-454 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Proficient Rx LP | 71205-579 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Preferred Pharmaceuticals, Inc. | 68788-7715 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | DirectRx | 72189-319 |