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NDC 63629-4970-01 Diclofenac Sodium and Misoprostol 75; 200 mg/1; ug/1 Details
Diclofenac Sodium and Misoprostol 75; 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 Bryant Ranch Prepack. 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: 63629-4970-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diclofenac and Misoprostol
Product Information
| NDC | 63629-4970 |
|---|---|
| Product ID | 63629-4970_8c7a84ca-915f-4e71-9bb0-3ca70a5ae517 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| 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 | 75; 200 |
| Active Ingredient Units | mg/1; ug/1 |
| Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
| Labeler Name | Bryant Ranch Prepack |
| 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 | ANDA201089 |
| Listing Certified Through | 2023-12-31 |
Package
NDC 63629-4970-01 (63629497001)
| NDC Package Code | 63629-4970-1 |
|---|---|
| Billing NDC | 63629497001 |
| Package | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4970-1) |
| Marketing Start Date | 2013-04-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |