Prescription drug · ANDA
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL NDC 85766-192
diclofenac sodium/misoprostol · Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet · Oral · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-192-07 | 85766019207 | 7 TABLET in 1 BOTTLE (85766-192-07)Marketed from Mar 24, 2026 | |
| 85766-192-10 | 85766019210 | 10 TABLET in 1 BOTTLE (85766-192-10)Marketed from Mar 24, 2026 | |
| 85766-192-14 | 85766019214 | 14 TABLET in 1 BOTTLE (85766-192-14)Marketed from Mar 24, 2026 | |
| 85766-192-15 | 85766019215 | 15 TABLET in 1 BOTTLE (85766-192-15)Marketed from Mar 24, 2026 | |
| 85766-192-20 | 85766019220 | 20 TABLET in 1 BOTTLE (85766-192-20)Marketed from Mar 24, 2026 | |
| 85766-192-30 | 85766019230 | 30 TABLET in 1 BOTTLE (85766-192-30)Marketed from Mar 24, 2026 | |
| 85766-192-60 | 85766019260 | 60 TABLET in 1 BOTTLE (85766-192-60)Marketed from Mar 24, 2026 | |
| 85766-192-90 | 85766019290 | 90 TABLET in 1 BOTTLE (85766-192-90)Marketed from Mar 24, 2026 |
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/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLSuffix: DICLOFENAC-SODIUM-MISOPROSTOL
- Generic name (nonproprietary)
- diclofenac sodium/misoprostol
- Active ingredients
- Diclofenac sodium — 75 mg/1Misoprostol — 200 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sportpharm LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204355
- 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 85766-192_4dc17730-088f-451b-e063-6294a90a032cSPL ID 4dc17730-088f-451b-e063-6294a90a032cSPL set ID 0d6509a1-7af8-473b-8951-c19439274379RxCUI 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
N485766019207followed by a unit qualifier and the quantityPackage 85766-0192-07. 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 arthr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204355
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 |
|---|---|---|---|---|
| DICLOENAC SODIUM and MISOPROSTOL DRdicloenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0273 |
| Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLdiclofenac sodium/misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | TabletOral | Micro Labs Limited | 42571-133 |
| Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLdiclofenac sodium/misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | TabletOral | Micro Labs Limited | 42571-134 |
| Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLdiclofenac sodium/misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2603 |