Search by Drug Name or NDC
NDC 42571-0133-29 Diclofenac Sodium/Misoprostol 50; 200 mg/1; ug/1 Details
Diclofenac Sodium/Misoprostol 50; 200 mg/1; ug/1
Diclofenac Sodium/Misoprostol is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Micro Labs Limited. 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: 42571-0133-29Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diclofenac and Misoprostol
Product Information
NDC | 42571-0133 |
---|---|
Product ID | 42571-133_f17fa649-8277-3ae8-e053-2a95a90a3c5b |
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/Misoprostol |
Proprietary Name Suffix | DICLOFENAC-SODIUM-MISOPROSTOL |
Non-Proprietary Name | Diclofenac Sodium/Misoprostol |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 50; 200 |
Active Ingredient Units | mg/1; ug/1 |
Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
Labeler Name | Micro Labs Limited |
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 | ANDA204355 |
Listing Certified Through | 2024-12-31 |
Package
NDC 42571-0133-29 (42571013329)
NDC Package Code | 42571-133-29 |
---|---|
Billing NDC | 42571013329 |
Package | 60 BLISTER PACK in 1 CARTON (42571-133-29) / 10 TABLET in 1 BLISTER PACK |
Marketing Start Date | 2021-09-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |