Prescription drug · NDA AUTHORIZED GENERIC
Diclofenac sodium and Misoprostol NDC 59762-0029
Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-0029-1 | 59762002901 | 60 TABLET, FILM COATED in 1 BOTTLE (59762-0029-1)Marketed from Nov 1, 2012 |
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
- Generic name (nonproprietary)
- diclofenac sodium and misoprostol
- Active ingredients
- Diclofenac sodium — 75 mg/1Misoprostol — 200 ug/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- 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 59762-0029_354b9b31-a5f4-4f05-b476-2759945ed43eSPL ID 354b9b31-a5f4-4f05-b476-2759945ed43eSPL set ID a7701e8c-4e16-4165-8b83-de2c08d5ded3RxCUI 857706, 1359105UNII 0E43V0BB57, QTG126297QUPC 0359762002914, 0359762002815
- 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
N459762002901followed by a unit qualifier and the quantityPackage 59762-0029-01. 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 DRdiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0272 |
| Diclofenac sodium and Misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-0028 |
| Arthrotecdiclofenac sodium and misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0025-1411 |