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NDC 53746-0193-01 Naproxen Sodium 275 mg/1 Details
Naproxen Sodium 275 mg/1
Naproxen Sodium is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is NAPROXEN SODIUM.
MedlinePlus Drug Summary
Prescription naproxen is used to relieve 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), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen 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: 53746-0193-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naproxen
Product Information
| NDC | 53746-0193 |
|---|---|
| Product ID | 53746-193_823ef251-7e4a-48c7-8bb1-9b73b8c6f420 |
| Associated GPIs | 66100060100305 |
| GCN Sequence Number | 008357 |
| GCN Sequence Number Description | naproxen sodium TABLET 275 MG ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 47130 |
| HICL Sequence Number | 003726 |
| HICL Sequence Number Description | NAPROXEN SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Naproxen Sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Naproxen Sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 275 |
| Active Ingredient Units | mg/1 |
| Substance Name | NAPROXEN SODIUM |
| Labeler Name | Amneal Pharmaceuticals of New York 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 | ANDA078432 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53746-0193-01 (53746019301)
| NDC Package Code | 53746-193-01 |
|---|---|
| Billing NDC | 53746019301 |
| Package | 100 TABLET in 1 BOTTLE (53746-193-01) |
| Marketing Start Date | 2007-04-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |