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NDC 00591-0397-19 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 Actavis Pharma, Inc.. 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: 00591-0397-19Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diclofenac and Misoprostol
Product Information
| NDC | 00591-0397 |
|---|---|
| Product ID | 0591-0397_5151188a-c6d7-4842-86a8-c1ac42375176 |
| 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 | Actavis Pharma, Inc. |
| 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 | 2024-12-31 |
Package
NDC 00591-0397-19 (00591039719)
| NDC Package Code | 0591-0397-19 |
|---|---|
| Billing NDC | 00591039719 |
| Package | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-19) |
| Marketing Start Date | 2012-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.99066 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | DICLOFENAC-MISOPROSTOL DR 50-0.2 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |