Prescription drug · ANDA
Diclofenac Potassium NDC 70512-750
Diclofenac potassium 50 mg/1 · Tablet, Film coated · Oral · SOLA Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70512-750-10 | 70512075010 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-10)Marketed from Oct 21, 2024 | |
| 70512-750-50 | 70512075050 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-50)Marketed from Dec 31, 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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- SOLA Pharmaceuticals, LLC
- 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 70512-750_47d44b29-dfd3-eace-e063-6394a90a4d24SPL ID 47d44b29-dfd3-eace-e063-6394a90a4d24SPL set ID e770efc8-bbad-4103-98e4-e31019a540f5RxCUI 855942UNII L4D5UA6CB4
- 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
N470512075010followed by a unit qualifier and the quantityPackage 70512-0750-10. 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 | 70512-900 |
| 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 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | Havix Group Inc d-b-a Aavis Pharmaceuticals | 71337-046 |