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Naproxen - Medication Information

Product NDC Code 65841-678
Drug Name

Naproxen

Type Generic
Pharm Class Anti-Inflammatory Agents,
Non-Steroidal [CS],
Cyclooxygenase Inhibitors [MoA],
Nonsteroidal Anti-inflammatory Drug [EPC]
Active Ingredients
Naproxen 500 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 198012,
198013,
198014
Application Number ANDA078620
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-678-01 100 tablet in 1 bottle (65841-678-01)
65841-678-05 500 tablet in 1 bottle (65841-678-05)
65841-678-10 1000 tablet in 1 bottle (65841-678-10)
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Spl product data elements

Usually a list of ingredients in a drug product.
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

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
Manufactured by: Cadila Healthcare Ltd. India SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API