Prescription drug · ANDA
Diclofenac Potassium NDC 71337-046
diclofenac potassium, film coated · Diclofenac potassium 50 mg/1 · Tablet · Oral · Havix Group Inc d-b-a Aavis Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71337-046-01 | 71337004601 | 100 TABLET in 1 BOTTLE (71337-046-01)Marketed from Jun 26, 2023 | |
| 71337-046-05 | 71337004605 | 500 TABLET in 1 BOTTLE (71337-046-05)Marketed from Jun 26, 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 Potassium
- Generic name (nonproprietary)
- diclofenac potassium, film coated
- Active ingredients
- Diclofenac potassium — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215787
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 71337-046_2a1e049f-58f9-40e8-b7a6-bcd19ef51f75SPL ID 2a1e049f-58f9-40e8-b7a6-bcd19ef51f75SPL set ID 30ab7b30-cc90-4b84-8caf-21058f1d37faRxCUI 855942UNII L4D5UA6CB4UPC 0371337046017
- 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
N471337004601followed by a unit qualifier and the quantityPackage 71337-0046-01. 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)
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 215787
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 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0456 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | Amerisyn LLC | 87564-011 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0457 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 25 mg/1 | TabletOral | Cintex Services, LLC | 24470-924 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 25 mg/1 | TabletOral | Happy Robin, LLC | 87127-802 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | PHOENIX RX LLC | 85509-1900 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Phoenix RX LLC | 85509-2750 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | SOLA Pharmaceuticals, LLC | 70512-750 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | SOLA Pharmaceuticals, LLC | 70512-900 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | Amici Pharma, Inc | 69292-552 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | VICI Pharmaceuticals, Inc | 87528-001 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-912 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 25 mg/1 | TabletOral | INA Pharmaceutics Inc, | 74157-016 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Doc Rx | 69306-750 |