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NDC 47335-0410-22 Sumatriptan and Naproxen Sodium 500; 85 mg/1; mg/1 Details
Sumatriptan and Naproxen Sodium 500; 85 mg/1; mg/1
Sumatriptan and Naproxen Sodium is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE.
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: 47335-0410-22Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naproxen
Sumatriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea or sensitivity to sound and light). Sumatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the head, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Sumatriptan does not prevent migraine attacks or reduce the number of headaches you have.
Related Packages: 47335-0410-22Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sumatriptan
Product Information
| NDC | 47335-0410 |
|---|---|
| Product ID | 47335-410_e0e3ea6e-7931-4279-880d-9d4f7d340acf |
| Associated GPIs | 67992002600320 |
| GCN Sequence Number | 063885 |
| GCN Sequence Number Description | sumatriptan succ/naproxen sod TABLET 85MG-500MG ORAL |
| HIC3 | H3F |
| HIC3 Description | ANTIMIGRAINE PREPARATIONS |
| GCN | 99597 |
| HICL Sequence Number | 035534 |
| HICL Sequence Number Description | SUMATRIPTAN SUCCINATE/NAPROXEN SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Sumatriptan and Naproxen Sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sumatriptan and Naproxen Sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500; 85 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE |
| Labeler Name | Sun Pharmaceutical Industries, Inc. |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202803 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 47335-0410-22 (47335041022)
| NDC Package Code | 47335-410-22 |
|---|---|
| Billing NDC | 47335041022 |
| Package | 9 TABLET, FILM COATED in 1 BOTTLE (47335-410-22) |
| Marketing Start Date | 2018-07-20 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 18.3344 |
| Pricing Unit | EA |
| Effective Date | 2023-10-18 |
| NDC Description | SUMATRIPTAN-NAPROXEN 85-500 MG |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |