Prescription drug · ANDA
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL (Diclofenac sodium/misoprostol) NDC 42571-133
Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 · Tablet · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-133-29 | 4257101332942571013329 | 60 BLISTER PACK in 1 CARTON (42571-133-29) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 1, 2021 | |
| 42571-133-30 | 4257101333042571013330 | 30 TABLET in 1 BOTTLE (42571-133-30)Marketed from Sep 1, 2021 | |
| 42571-133-60 | 4257101336042571013360 | 60 TABLET in 1 BOTTLE (42571-133-60)Marketed from Sep 1, 2021 | |
| 42571-133-90 | 4257101339042571013390 | 90 TABLET in 1 BOTTLE (42571-133-90)Marketed from Sep 1, 2021 |
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 — 50 mg/1Misoprostol — 200 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Micro Labs LimitedNDC labeler code 42571
- 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 42571-133_3afc5367-562f-b4a0-e063-6294a90a2560SPL ID 3afc5367-562f-b4a0-e063-6294a90a2560SPL set ID c61df58d-d6bb-4d3e-9ef8-60caa7d4e762RxCUI 857706, 1359105UNII QTG126297Q, 0E43V0BB57UPC 0342571133603, 0342571134600
- 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
N442571013329followed by a unit qualifier and the quantityPackage 42571-0133-29. 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.
About NDC 42571-133
- What is NDC 42571-133?
- 42571-133 is the product NDC for Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL, Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 tablet, listed with the FDA by Micro Labs Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL (Diclofenac Sodium/Misoprostol).
- What is the active ingredient?
- Diclofenac sodium, Misoprostol.
- Who is the labeler?
- Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL?
- 3 other product NDCs are listed under this name. See all Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLdiclofenac sodium/misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | TabletOral | Micro Labs Limited | 42571-134 | 42571-0134-2942571-0134-3042571-0134-60+1 more |
| Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLdiclofenac sodium/misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2603 | 71335-2603-0171335-2603-0271335-2603-03+2 more |
| Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLdiclofenac sodium/misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | TabletOral | Sportpharm LLC | 85766-192 | 85766-0192-0785766-0192-1085766-0192-14+5 more |
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 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 |
| Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLdiclofenac sodium/misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | TabletOral | Sportpharm LLC | 85766-192 |