Prescription drug · ANDA
Diclofenac Sodium Misoprostol NDC 72162-2518
diclofenac sodium and misoprostol · Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2518-6 | 72162251806 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2518-6)Marketed from Jul 15, 2021 |
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 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205143
- 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 72162-2518_4f4755a3-4605-4418-8456-4b917ad15c32SPL ID 4f4755a3-4605-4418-8456-4b917ad15c32SPL set ID de4c02a5-87e8-42f5-a9ff-f409ff9e6d62RxCUI 857706UNII 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
N472162251806followed by a unit qualifier and the quantityPackage 72162-2518-06. 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 the treatment of signs and symptoms of osteoarthritis or rheumatoid arthri…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205143
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 Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 71205-866 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 71205-865 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Nivagen Pharmaceuticals, Inc. | 75834-265 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Nivagen Pharmaceuticals, Inc. | 75834-264 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 72162-2519 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2441 |