Prescription drug · ANDA
Diclofenac Sodium NDC 70512-810
Diclofenac sodium 16.05 mg/mL · Solution · Topical · SOLA Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70512-810-05 | 70512081005 | 1 BOTTLE, DROPPER in 1 BOX (70512-810-05) / 150 mL in 1 BOTTLE, DROPPERMarketed from Jul 1, 2023 |
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 — 16.05 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- SOLA Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206116
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 70512-810_4a684065-ba9a-819c-e063-6394a90ac670SPL ID 4a684065-ba9a-819c-e063-6394a90ac670SPL set ID 11e88ced-cdcf-4101-9297-c4c3dde9d089RxCUI 857700UNII QTG126297QUPC 0370512810054
- 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
N470512081005followed by a unit qualifier and the quantityPackage 70512-0810-05. 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 is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). 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 206116
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 Sodiumdiclofenac | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Proficient Rx LP | 71205-811 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | DIRECT RX | 72189-075 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0237 |
| Diclofenac Sodiumdiclofenac | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-7270 |
| Diclofenac Sodiumdiclofenac | Diclofenac sodium 16.05 mg/mL | SolutionTopical | A-S Medication Solutions | 50090-3316 |
| Diclofenac Sodiumdiclofenac | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Asclemed USA, Inc. | 76420-012 |
| Diclofenac Sodiumdiclofenac | Diclofenac sodium 16.05 mg/mL | SolutionTopical | PHOENIX RX LLC | 85509-1911 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Direct_Rx | 72189-527 |
| Diclofenac Sodiumdiclofenac | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Amneal Pharmaceuticals LLC | 65162-911 |
| Diclofenac Sodiumdiclofenac | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Bryant Ranch Prepack | 72162-2031 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Advanced Rx of Tennessee, LLC | 80425-0368 |