Prescription drug · ANDA
Diclofenac Sodium DR (Diclofenac sodium) NDC 80425-0055
Diclofenac sodium 75 mg/1 · Tablet, Delayed release · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0055-1 | 80425005501 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0055-1)Marketed from Nov 13, 1998 |
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 DRSuffix: DR
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 75 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075185
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 80425-0055_2a806f57-0229-a1fc-e063-6394a90a1ffaSPL ID 2a806f57-0229-a1fc-e063-6394a90a1ffaSPL set ID af8a1392-67e8-8201-e053-2a95a90a0fceRxCUI 855926UNII 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
N480425005501followed by a unit qualifier and the quantityPackage 80425-0055-01. 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 Section Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). Diclofenac is 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.
About NDC 80425-0055
- What is NDC 80425-0055?
- 80425-0055 is the product NDC for Diclofenac Sodium DR (diclofenac sodium), Diclofenac sodium 75 mg/1 tablet, delayed release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Sodium DR (Diclofenac Sodium).
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diclofenac Sodium DR?
- 2 other product NDCs are listed under this name. See all Diclofenac Sodium DR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diclofenac Sodium DR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diclofenac Sodium DRdiclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0197 | 80425-0197-0280425-0197-03 |
| Diclofenac Sodium DRdiclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0189 | 80425-0189-0180425-0189-0280425-0189-03 |
Other NDCs under ANDA 075185
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 | AvKARE | 42291-230 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | AvKARE | 42291-231 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | RedPharm Drug, Inc. | 67296-1197 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | SOLA Pharmaceuticals, LLC | 70512-784 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0564 |
| Diclofenac Sodium D/R | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | DirectRx | 72189-675 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-0542 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-0543 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-0545 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-7818 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-7838 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-7839 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-7880 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-7881 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 25 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-536 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-537 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-538 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-967 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-968 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Northwind Health Company, LLC | 51655-176 |
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