Prescription drug · ANDA
Diclofenac Potassium NDC 69292-548
Diclofenac potassium 25 mg/1 · Tablet, Film coated · Oral · Amici Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69292-548-30 | 69292054830 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69292-548-30)Marketed from Apr 18, 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 Potassium
- Generic name (nonproprietary)
- diclofenac potassium
- Active ingredients
- Diclofenac potassium — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amici Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076561
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 69292-548_cf4973de-8da2-4fdf-8f48-938627e09d5aSPL ID cf4973de-8da2-4fdf-8f48-938627e09d5aSPL set ID f2908870-a517-491f-8771-4100d11b4b64RxCUI 855942, 857702UNII L4D5UA6CB4UPC 0369292548301
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469292054830followed by a unit qualifier and the quantityPackage 69292-0548-30. 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)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac potassium tablets are indicated: For treatment of primary dysmenorrhea For relief of mild to moderate pain For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076561
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 Potassium | Diclofenac potassium 25 mg/1 | Tablet, Film coatedOral | Carwin Pharmaceutical Associates, LLC | 15370-185 |
| Lofenadiclofenac potassium | Diclofenac potassium 25 mg/1 | Tablet, Film coatedOral | Carwin Pharmaceutical Associates, LLC | 15370-180 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-443 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Amici Pharma Inc. | 69292-550 |