Naproxen
- Naproxen NAPROXEN 500 mg/1 MARKSANS PHARMA LIMITED
- Naproxen NAPROXEN 500 mg/1 NCS HealthCare of KY, Inc dba Vangard Labs
- NAPROXEN NAPROXEN 500 mg/1 Asclemed USA, Inc.
- Naproxen NAPROXEN 500 mg/1 Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- NAPROXEN NAPROXEN 500 mg/1 DIRECT RX
- Naproxen NAPROXEN 500 mg/1 Preferred Pharmaceuticals Inc.
- Naproxen NAPROXEN 500 mg/1 Bryant Ranch Prepack
- Naproxen NAPROXEN 500 mg/1 REMEDYREPACK INC.
- NAPROXEN NAPROXEN 500 mg/1 Direct_Rx
- NAPROXEN NAPROXEN 500 mg/1 Direct_Rx
- Naproxen NAPROXEN 500 mg/1 Pharmasource Meds, LLC
- Naproxen NAPROXEN 500 mg/1 A-S Medication Solutions
- Naproxen NAPROXEN 500 mg/1 Aurobindo Pharma Limited
- NAPROXEN NAPROXEN 500 mg/1 DIRECT RX
- Naproxen NAPROXEN 500 mg/1 Bryant Ranch Prepack
- Naproxen NAPROXEN 500 mg/1 RPK Pharmaceuticals, Inc.
- Naproxen NAPROXEN 500 mg/1 REMEDYREPACK INC.
- Naproxen NAPROXEN 500 mg/1 PD-Rx Pharmaceuticals, Inc.
- Naproxen NAPROXEN 500 mg/1 Zydus Lifesciences Limited
- Naproxen NAPROXEN 500 mg/1 St. Mary's Medical Park Pharmacy
- NAPROXEN NAPROXEN 500 mg/1 medsource pharmaceuticals
- Naproxen NAPROXEN 500 mg/1 Asclemed USA, Inc.
- Naproxen NAPROXEN 500 mg/1 A-S Medication Solutions
- Naproxen NAPROXEN 500 mg/1 A-S Medication Solutions
- NAPROXEN NAPROXEN 500 mg/1 Northwind Pharmaceuticals, LLC
- Naproxen NAPROXEN 500 mg/1 Amneal Pharmaceuticals LLC
- Naproxen NAPROXEN 500 mg/1 McKesson Corporation dba SKY Packaging
- Naproxen NAPROXEN 500 mg/1 Asclemed USA, Inc.
- Naproxen NAPROXEN 500 mg/1 Cameron Pharmaceuticals
- Naproxen NAPROXEN 500 mg/1 Proficient Rx LP
- Naproxen NAPROXEN 500 mg/1 American Health Packaging
- Naproxen NAPROXEN 500 mg/1 Exelan Pharmaceuticals, Inc.
- NAPROXEN NAPROXEN 500 mg/1 TIME CAP LABORATORIES
- Naproxen NAPROXEN 500 mg/1 A-S Medication Solutions
- Naproxen NAPROXEN 500 mg/1 A-S Medication Solutions
- Naproxen NAPROXEN 500 mg/1 Amneal Pharmaceuticals LLC
- Naproxen NAPROXEN 500 mg/1 Cipla USA Inc.
- Naproxen NAPROXEN 500 mg/1 NuCare Pharmaceuticals,Inc.
- Naproxen NAPROXEN 500 mg/1 Redpharm Drug
- Naproxen NAPROXEN 500 mg/1 Proficient Rx LP
- Naproxen NAPROXEN 500 mg/1 Aphena Pharma Solutions - Tennessee, LLC
- Naproxen NAPROXEN 500 mg/1 A-S Medication Solutions
- Naproxen NAPROXEN 500 mg/1 ScieGen Pharmaceuticals, Inc.
- Naproxen NAPROXEN 500 mg/1 REMEDYREPACK INC.
- Naproxen NAPROXEN 500 mg/1 A-S Medication Solutions
- NAPROXEN NAPROXEN 500 mg/1 PD-Rx Pharmaceuticals, Inc.
- Naprosyn NAPROXEN 500 mg/1 Canton Laboratories
- Naproxen NAPROXEN 500 mg/1 Advanced Rx Pharmacy of Tennessee, LLC
- Naproxen NAPROXEN 500 mg/1 REMEDYREPACK INC.
- NAPROXEN NAPROXEN 500 mg/1 RPK Pharmaceuticals, Inc.
- Naproxen NAPROXEN 500 mg/1 Quality Care Products, LLC
- Naproxen NAPROXEN 500 mg/1 Radha Pharmaceuticals, Inc.
- NAPROXEN NAPROXEN 500 mg/1 Direct RX
- Naproxen NAPROXEN 500 mg/1 A-S Medication Solutions
- Naproxen NAPROXEN 500 mg/1 QPharma, Inc.
- Naproxen NAPROXEN 500 mg/1 RPK Pharmaceuticals, Inc.
- Naproxen NAPROXEN 500 mg/1 RPK Pharmaceuticals, Inc.
- NAPROXEN NAPROXEN 500 mg/1 QPharma Inc
- Naproxen NAPROXEN 500 mg/1 A-S Medication Solutions
- Naproxen NAPROXEN 500 mg/1 A-S Medication Solutions
- Naproxen NAPROXEN 500 mg/1 ScieGen Pharmaceuticals, Inc.
- Naproxen NAPROXEN 500 mg/1 PD-Rx Pharmaceuticals, Inc.
- Naproxen NAPROXEN 500 mg/1 Northwind Pharmaceuticals, LLC
- Naproxen NAPROXEN 500 mg/1 Zydus Pharmaceuticals USA Inc.
- Naproxen NAPROXEN 500 mg/1 Proficient Rx LP
- Naproxen NAPROXEN 500 mg/1 Lake Erie Medical DBA Quality Care Products LLC
- NAPROXEN NAPROXEN 500 mg/1 Direct_Rx
- Naproxen NAPROXEN 500 mg/1 Amneal Pharmaceuticals of New York LLC
- NAPROXEN NAPROXEN 500 mg/1 DIRECT RX
- NAPROXEN NAPROXEN 500 mg/1 H.J. Harkins Company., Inc.
- NAPROXEN NAPROXEN 500 mg/1 PD-Rx Pharmaceuticals, Inc.
- Naproxen NAPROXEN 500 mg/1 Amneal Pharmaceuticals LLC
- Naproxen NAPROXEN 500 mg/1 A-S Medication Solutions
- Naproxen NAPROXEN 500 mg/1 Northwind Pharmaceuticals
Summary of product characteristics
Effective Time
20230927
Version
5
Spl Product Data Elements
Naproxen Naproxen NAPROXEN NAPROXEN CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW MAGNESIUM STEARATE POVIDONE ZE10 Naproxen Naproxen NAPROXEN NAPROXEN CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW MAGNESIUM STEARATE POVIDONE yellow ZE9 Naproxen Naproxen NAPROXEN NAPROXEN CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW MAGNESIUM STEARATE POVIDONE ZE8
Application Number
ANDA078620
Brand Name
Naproxen
Generic Name
Naproxen
Product Ndc
65841-678
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-676-01 Naproxen tablets, 250 mg 100 Tablets Rx only NDC 65841-677-01 Naproxen tablets, 375 mg 100 Tablets Rx only NDC 65841-678-01 Naproxen tablets, 500 mg 100 Tablets Rx only Naproxen tablets Naproxen tablets Naproxen tablets
Spl Medguide
Manufactured by: Cadila Healthcare Ltd. India
Drug section
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
Disclaimer
The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).
Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.
Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.