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NDC 69344-0101-01 Indocin 25 mg/5mL Details
Indocin 25 mg/5mL
Indocin is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zyla Life Sciences US 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: 69344-0101-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Indomethacin
Product Information
| NDC | 69344-0101 |
|---|---|
| Product ID | 69344-101_f12331c3-419d-4797-9f43-b28289acd0b4 |
| Associated GPIs | 66100030001805 |
| GCN Sequence Number | 008341 |
| GCN Sequence Number Description | indomethacin ORAL SUSP 25 MG/5 ML ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 36490 |
| HICL Sequence Number | 003719 |
| HICL Sequence Number Description | INDOMETHACIN |
| Brand/Generic | Brand |
| Proprietary Name | Indocin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | indomethacin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/5mL |
| Substance Name | INDOMETHACIN |
| Labeler Name | Zyla Life Sciences US LLC |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA018332 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69344-0101-01 (69344010101)
| NDC Package Code | 69344-101-01 |
|---|---|
| Billing NDC | 69344010101 |
| Package | 1 BOTTLE, GLASS in 1 CARTON (69344-101-01) / 237 mL in 1 BOTTLE, GLASS |
| Marketing Start Date | 2019-02-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |