Prescription drug · NDA
Arthrotec (Diclofenac sodium and misoprostol) NDC 0025-1411
Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 · Tablet, Film coated · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0025-1411-60 | 0002514116000025141160 | 60 TABLET, FILM COATED in 1 BOTTLE (0025-1411-60)Marketed from Dec 24, 1997 | |
| 0025-1411-90 | 0002514119000025141190 | 90 TABLET, FILM COATED in 1 BOTTLE (0025-1411-90)Marketed from Dec 24, 1997 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Arthrotec
- Generic name (nonproprietary)
- diclofenac sodium and misoprostol
- Active ingredients
- Diclofenac sodium — 50 mg/1Misoprostol — 200 ug/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0025
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020607
- 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 0025-1411_2b1bf1d7-4399-46bd-8654-2590513da5c2SPL ID 2b1bf1d7-4399-46bd-8654-2590513da5c2SPL set ID 600fe842-45d9-4d68-9ef2-456dbbebaa11RxCUI 857706, 1359105, 1359107, 1359109UNII QTG126297Q, 0E43V0BB57UPC 0300251411601, 0300251421600
- 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
N400025141160followed by a unit qualifier and the quantityPackage 00025-1411-60. 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)
ARTHROTEC is 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) ] . ARTHROTEC is 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 arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and the…
Excerpt only. Read the full label for complete information.
About NDC 0025-1411
- What is NDC 0025-1411?
- 0025-1411 is the product NDC for Arthrotec, Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 tablet, film coated, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Arthrotec (Diclofenac sodium and misoprostol).
- What is the active ingredient?
- Diclofenac sodium, Misoprostol.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0025. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Arthrotec?
- 1 other product NDC are listed under this name. See all Arthrotec NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Arthrotec products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Arthrotecdiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0025-1421 | 00025-1421-60 |
Other NDCs under NDA 020607
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 |
|---|---|---|---|---|
| Arthrotecdiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0025-1421 |
| Diclofenac sodium and Misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-0028 |
| Diclofenac sodium and Misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-0029 |
| Diclofenac sodium and Misoprostol DRdiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0272 |