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NDC 70748-0216-07 NAPROXEN AND ESOMEPRAZOLE MAGNESIUM 20; 500 mg/1; mg/1 Details
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM 20; 500 mg/1; mg/1
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is ESOMEPRAZOLE MAGNESIUM; NAPROXEN.
MedlinePlus Drug Summary
Prescription esomeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription esomeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription esomeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription esomeprazole is also used to decrease the chance that people who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) will develop ulcers (sores in the lining of the stomach or intestine) in adults. It is also used with other medications to treat and prevent the return of stomach ulcers caused by a certain type of bacteria (H. pylori) in adults. Prescription esomeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Nonprescription (over-the-counter) esomeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.
Related Packages: 70748-0216-07Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Esomeprazole
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: 70748-0216-07Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Naproxen
Product Information
| NDC | 70748-0216 |
|---|---|
| Product ID | 70748-216_299bc1f9-3164-4413-8c94-a972b1d98463 |
| Associated GPIs | 66109902440640 |
| GCN Sequence Number | 066328 |
| GCN Sequence Number Description | naproxen/esomeprazole mag TAB IR DR 500MG-20MG ORAL |
| HIC3 | S2P |
| HIC3 Description | NSAID,COX INHIBITOR-TYPE AND PROTON-PUMP INHIBITOR |
| GCN | 28570 |
| HICL Sequence Number | 036964 |
| HICL Sequence Number Description | NAPROXEN/ESOMEPRAZOLE MAGNESIUM |
| Brand/Generic | Generic |
| Proprietary Name | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 20; 500 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
| Labeler Name | Lupin Pharmaceuticals, Inc. |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA022511 |
| Listing Certified Through | 2023-12-31 |
Package
NDC 70748-0216-07 (70748021607)
| NDC Package Code | 70748-216-07 |
|---|---|
| Billing NDC | 70748021607 |
| Package | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (70748-216-07) |
| Marketing Start Date | 2020-03-04 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 5.38313 |
| Pricing Unit | EA |
| Effective Date | 2023-03-22 |
| NDC Description | NAPROXEN-ESOMEPRAZ DR 500-20 MG |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 6 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |