Prescription drug · ANDA
Diclofenac Sodium NDC 60760-953
Diclofenac sodium 100 mg/1 · Tablet, Extended release · Oral · ST. MARY'S MEDICAL PARK PHARMACY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60760-953-30 | 60760095330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-953-30)Marketed from Mar 18, 2026 |
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 — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076201
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 60760-953_4ddd42ef-1d1b-8b3b-e063-6394a90a8a3aSPL ID 4ddd42ef-1d1b-8b3b-e063-6394a90a8a3aSPL set ID 4ddd7e34-e5f4-8f05-e063-6294a90a70aaRxCUI 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
N460760095330followed by a unit qualifier and the quantityPackage 60760-0953-30. 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 & USAGE Carefully consider the potential benefits and risks of diclofenac sodium extended release tablets, USP 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 076201
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, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3556 |
| Diclofenac Sodium | Diclofenac sodium 100 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals, LLC. | 68071-3720 |
| Diclofenac Sodium | Diclofenac sodium 100 mg/1 | Tablet, Extended releaseOral | Edenbridge Pharmaceuticals LLC. | 42799-953 |