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NDC 42708-0043-20 Naproxen 500 mg/1 Details

Naproxen 500 mg/1

Naproxen is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by QPharma, Inc.. The primary component is NAPROXEN.

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: 42708-0043-20
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naproxen

Product Information

NDC	42708-0043
Product ID	42708-043_0335db7c-5cf8-645e-e063-6394a90a0172
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Naproxen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Naproxen
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	NAPROXEN
Labeler Name	QPharma, Inc.
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	ANDA075927
Listing Certified Through	2024-12-31

Package

NDC 42708-0043-20 (42708004320)

Pricing Information	N/A
NDC Package Code	42708-043-20
Billing NDC	42708004320
Package	20 TABLET in 1 BOTTLE (42708-043-20)
Marketing Start Date	2018-03-14
NDC Exclude Flag	N