Search by Drug Name or NDC
NDC 68001-0232-06 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 BluePoint Laboratories. 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: 68001-0232-06Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diclofenac and Misoprostol
Product Information
NDC | 68001-0232 |
---|---|
Product ID | 68001-232_f9d6d774-a103-2ccc-e053-6294a90a0629 |
Associated GPIs | 66109902200630 |
GCN Sequence Number | 035737 |
GCN Sequence Number Description | diclofenac sodium/misoprostol TAB IR DR 75 MG-200 ORAL |
HIC3 | S2T |
HIC3 Description | NSAIDS(COX NON-SPEC.INHIB)AND PROSTAGLANDIN ANALOG |
GCN | 06263 |
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 | 75; 200 |
Active Ingredient Units | mg/1; ug/1 |
Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
Labeler Name | BluePoint Laboratories |
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 68001-0232-06 (68001023206)
NDC Package Code | 68001-232-06 |
---|---|
Billing NDC | 68001023206 |
Package | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-232-06) |
Marketing Start Date | 2014-02-26 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 1.11251 |
Pricing Unit | EA |
Effective Date | 2024-02-21 |
NDC Description | DICLOFENAC-MISOPROSTOL DR 75-0.2 MG TABLET |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |