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NDC 65162-0506-50 Indomethacin 75 mg/1 Details
Indomethacin 75 mg/1
Indomethacin is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is INDOMETHACIN.
MedlinePlus Drug Summary
Indomethacin is used to relieve moderate to severe pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), and ankylosing spondylitis (arthritis that mainly affects the spine). Indomethacin is also used to treat pain in the shoulder caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint) and tendinitis (inflammation of the tissue that connects muscle to bone). Indomethacin immediate-release capsules and suspension (liquid) are also used to treat acute gouty arthritis (attacks of severe joint pain and swelling caused by a build-up of certain substances in the joints). Indomethacin is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 65162-0506-50Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Indomethacin
Product Information
| NDC | 65162-0506 |
|---|---|
| Product ID | 65162-506_c159c603-0fae-480a-9344-6364def07c80 |
| Associated GPIs | 66100030000205 |
| GCN Sequence Number | 008338 |
| GCN Sequence Number Description | indomethacin CAPSULE ER 75 MG ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 35690 |
| HICL Sequence Number | 003719 |
| HICL Sequence Number Description | INDOMETHACIN |
| Brand/Generic | Generic |
| Proprietary Name | Indomethacin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Indomethacin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 75 |
| Active Ingredient Units | mg/1 |
| Substance Name | INDOMETHACIN |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091549 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0506-50 (65162050650)
| NDC Package Code | 65162-506-50 |
|---|---|
| Billing NDC | 65162050650 |
| Package | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-50) |
| Marketing Start Date | 2010-12-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |