Prescription drug · ANDA
Diclofenac Sodium and Misoprostol NDC 68001-231
Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed release · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-231-06 | 68001023106 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-231-06)Marketed from Feb 26, 2014 |
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 — 50 mg/1Misoprostol — 200 ug/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- BluePoint Laboratories
- 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 68001-231_3e847cfc-d342-3a15-e063-6394a90aeb46SPL ID 3e847cfc-d342-3a15-e063-6394a90aeb46SPL set ID 9a22cb4b-e49a-4bd7-b235-47405c302658RxCUI 857706, 1359105UNII 0E43V0BB57, QTG126297QUPC 0368001232067, 0368001231060
- 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
N468001023106followed by a unit qualifier and the quantityPackage 68001-0231-06. 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 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 and misoprostol delayed-release tablets are a combination of diclofenac sodium, a non-steroidal anti-inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthrit…
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 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | AvKARE | 42291-233 |
| 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 |