Prescription drug · NDA AUTHORIZED GENERIC
Diclofenac sodium and Misoprostol DR NDC 80425-0272
diclofenac sodium and misoprostol · Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet, Film coated · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0272-1 | 80425027201 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0272-1)Marketed from Feb 23, 2024 |
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 and Misoprostol DRSuffix: DR
- Generic name (nonproprietary)
- diclofenac sodium and misoprostol
- Active ingredients
- Diclofenac sodium — 75 mg/1Misoprostol — 200 ug/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020607
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)Synthetic (Chemical structure)
- Identifiers
- Product ID 80425-0272_1213898d-dffc-ce28-e063-6394a90a1a28SPL ID 1213898d-dffc-ce28-e063-6394a90a1a28SPL set ID 1213d3eb-9870-f144-e063-6394a90a6088RxCUI 1359105UNII QTG126297Q, 0E43V0BB57
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; Prostaglandin E1 Analog
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
N480425027201followed by a unit qualifier and the quantityPackage 80425-0272-01. 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)
Diclofenac sodium/misoprostol is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3) ] . Diclofenac sodium/misoprostol is a combination of diclofenac sodium, a non‑steroidal anti‑inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID‑ind…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020607
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 |
|---|---|---|---|---|
| Arthrotecdiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0025-1421 |
| Diclofenac sodium and Misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-0028 |
| Diclofenac sodium and Misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-0029 |
| Arthrotecdiclofenac sodium and misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0025-1411 |