Prescription drug · ANDA
Diclofenac Sodium NDC 55289-150
Diclofenac sodium 75 mg/1 · Tablet, Delayed release · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-150-10 | 55289015010 | 10 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-10)Marketed from Mar 31, 2011 | |
| 55289-150-15 | 55289015015 | 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-15)Marketed from Mar 31, 2011 | |
| 55289-150-20 | 55289015020 | 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-20)Marketed from Mar 31, 2011 | |
| 55289-150-28 | 55289015028 | 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-28)Marketed from Mar 31, 2011 | |
| 55289-150-30 | 55289015030 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-30)Marketed from Mar 31, 2011 | |
| 55289-150-60 | 55289015060 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-60)Marketed from Mar 31, 2011 |
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 — 75 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074514
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 55289-150_3466672c-1212-3459-e063-6294a90a1288SPL ID 3466672c-1212-3459-e063-6294a90a1288SPL set ID 87d5a720-f154-4c4b-b2d4-0ae58455dda0RxCUI 855926UNII QTG126297QUPC 0355289150305
- 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
N455289015010followed by a unit qualifier and the quantityPackage 55289-0150-10. 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 sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-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 delayed-release tablets are indicated: for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074514
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 50 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-0538 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-0539 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-068 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 60429-421 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-761 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 60429-422 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Actavis Pharma, Inc. | 0228-2550 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-467 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Actavis Pharma, Inc. | 0228-2551 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-522 |