Prescription drug · ANDA
Diclofenac sodium NDC 70518-4044
Diclofenac sodium 100 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4044-0 | 70518404400 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4044-0)Marketed from Apr 5, 2024 | |
| 70518-4044-1 | 70518404401 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4044-1)Marketed from Jun 13, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216275
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 70518-4044_54116d64-d7bc-666a-e063-6394a90adea5SPL ID 54116d64-d7bc-666a-e063-6394a90adea5SPL set ID 6980431d-4a2b-41e9-ae86-d46b4513f04bRxCUI 855657UNII QTG126297Q
- 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
N470518404400followed by a unit qualifier and the quantityPackage 70518-4044-00. 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 sodium extended-release tablets and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac sodium extended-release tablets are indicated: 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 216275
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 100 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0414 |
| Diclofenac sodium | Diclofenac sodium 100 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-598 |
| Diclofenac sodium | Diclofenac sodium 100 mg/1 | Tablet, Film coatedOral | Ingenus Pharmaceuticals, LLC | 50742-278 |
| Diclofenac sodium | Diclofenac sodium 100 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-032 |
| Diclofenac sodium | Diclofenac sodium 100 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-612 |
| Diclofenac sodium | Diclofenac sodium 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9665 |