Prescription drug · ANDA
Diclofenac Sodium and Misoprostol NDC 42291-233
Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed release · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-233-60 | 42291023360 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-233-60)Marketed from Dec 14, 2012 |
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 and Misoprostol
- Generic name (nonproprietary)
- diclofenac sodium and misoprostol
- Active ingredients
- Diclofenac sodium — 75 mg/1Misoprostol — 200 ug/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201089
- 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 42291-233_4dc7edc1-b426-ac49-e063-6294a90af71bSPL ID 4dc7edc1-b426-ac49-e063-6294a90af71bSPL set ID 3643ab1b-9f8f-b2f4-e02d-950d0a02e587RxCUI 857706, 1359105UNII 0E43V0BB57, QTG126297Q
- 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
N442291023360followed by a unit qualifier and the quantityPackage 42291-0233-60. 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 and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in 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 (5.2) ]. Diclofenac sodium and misoprostol delayed-release tablets are a combination non-steroidal anti-inflammatory and prostaglandin E 1 analog drug indicated for the treatment of signs and symptoms of osteoarthritis (OA) or rheumatoid arthritis (RA) in patients at high risk of developing …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201089
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 and Misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | AvKARE | 42291-232 |
| Diclofenac Sodium and Misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Actavis Pharma, Inc. | 0591-0397 |
| Diclofenac Sodium and Misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Actavis Pharma, Inc. | 0591-0398 |
| Diclofenac Sodium and Misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | BluePoint Laboratories | 68001-232 |
| Diclofenac Sodium and Misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | BluePoint Laboratories | 68001-231 |