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NDC 69344-0102-33 INDOCIN 50 mg/1 Details
INDOCIN 50 mg/1
INDOCIN is a RECTAL SUPPOSITORY 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 (swelling of a fluid-filled sac in the shoulder joint) and tendinitis (swelling of the tissue that connects muscle to bone). Indomethacin suppositories 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). It is used to treat moderate to severe rheumatoid arthritis. 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 swelling.
Related Packages: 69344-0102-33Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Indomethacin Rectal
Product Information
| NDC | 69344-0102 |
|---|---|
| Product ID | 69344-102_848f696a-1807-4425-8904-fdeb275f939d |
| Associated GPIs | 66100030005205 |
| GCN Sequence Number | 008340 |
| GCN Sequence Number Description | indomethacin SUPP.RECT 50 MG RECTAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 20240 |
| 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 | SUPPOSITORY |
| Route | RECTAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| 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 | ANDA |
| Application Number | ANDA073314 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69344-0102-33 (69344010233)
| NDC Package Code | 69344-102-33 |
|---|---|
| Billing NDC | 69344010233 |
| Package | 30 SUPPOSITORY in 1 BOX (69344-102-33) |
| Marketing Start Date | 1992-08-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |