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NDC 65162-0436-03 Diclofenac Sodium and Misoprostol 50; 200 mg/1; ug/1 Details
Diclofenac Sodium and Misoprostol 50; 200 mg/1; ug/1
Diclofenac Sodium and Misoprostol is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is DICLOFENAC SODIUM; MISOPROSTOL.
MedlinePlus Drug Summary
The combination of diclofenac and misoprostol is used to relieve the pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints) in patients who have a high risk of developing stomach ulcers. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain and inflammation. Misoprostol is in a class of medications called prostaglandins. It prevents ulcers caused by diclofenac by protecting the stomach lining and decreasing stomach acid production.
Related Packages: 65162-0436-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diclofenac and Misoprostol
Product Information
| NDC | 65162-0436 |
|---|---|
| Product ID | 65162-436_563b0390-b986-4b4d-a46a-8ea894d4d1be |
| Associated GPIs | 66109902200620 |
| GCN Sequence Number | 020279 |
| GCN Sequence Number Description | diclofenac sodium/misoprostol TAB IR DR 50 MG-200 ORAL |
| HIC3 | S2T |
| HIC3 Description | NSAIDS(COX NON-SPEC.INHIB)AND PROSTAGLANDIN ANALOG |
| GCN | 62729 |
| HICL Sequence Number | 008302 |
| HICL Sequence Number Description | DICLOFENAC SODIUM/MISOPROSTOL |
| Brand/Generic | Generic |
| Proprietary Name | Diclofenac Sodium and Misoprostol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diclofenac Sodium and Misoprostol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 50; 200 |
| Active Ingredient Units | mg/1; ug/1 |
| Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203995 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0436-03 (65162043603)
| NDC Package Code | 65162-436-03 |
|---|---|
| Billing NDC | 65162043603 |
| Package | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-436-03) |
| Marketing Start Date | 2016-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |