Prescription drug · ANDA
Diclofenac Sodium NDC 82804-160
Diclofenac sodium 20 mg/g · Solution · Topical · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-160-12 | 82804016012 | 1 BOTTLE in 1 CARTON (82804-160-12) / 112 g in 1 BOTTLEMarketed from Nov 11, 2024 |
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 — 20 mg/g
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213040
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 82804-160_ba4677e4-00f8-44f6-a69b-e88ca28f6b2bSPL ID ba4677e4-00f8-44f6-a69b-e88ca28f6b2bSPL set ID ba4677e4-00f8-44f6-a69b-e88ca28f6b2bRxCUI 1487074UNII QTG126297QUPC 0382804160129
- 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
N482804016012followed by a unit qualifier and the quantityPackage 82804-0160-12. 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)
1. INDICATIONS AND USAGE Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s). Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s). (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213040
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 20 mg/g | SolutionTopical | NorthStar Rx LLC | 72603-207 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | A-S Medication Solutions | 50090-7632 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-8541 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | Aurolife Pharma LLC | 13107-269 |
| Diclofenac Sodium Topical Solution | Diclofenac sodium 20 mg/g | SolutionTopical | Direct_Rx | 72189-546 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | Asclemed USA, Inc | 76420-861 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | Proficient Rx LP | 82804-074 |