54569-4520 : Naproxen Delayed Release 500 mg Oral Tablet


NDC: 54569-4520
Labeler: A-s Medication Solutions
Product Type: Human Prescription Drug
Drug Name:  Naproxen Delayed Release
Dosage Form: Oral Tablet
Application #: ANDA091432
Rev. Date: 


Appearance:


Markings: I;11
Shapes:  Oval
Colors:  White
Size (mm): 16
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

I 11: (31722-339) Naproxen Delayed Release 500 mg Oral Tablet by A-s Medication Solutions
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 54569-4520-0: 15 TABLET IN 1 BOTTLE (54569‑4520‑0)
  • 54569-4520-1: 30 TABLET IN 1 BOTTLE (54569‑4520‑1)
  • 54569-4520-3: 60 TABLET IN 1 BOTTLE (54569‑4520‑3)

Active Ingredients:

  • Naproxen

Dosage Strength:

  • 500 mg

Inactive Ingredients:

  • Povidones
  • Silicon Dioxide
  • Magnesium Stearate
  • Croscarmellose Sodium
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Talc
  • Titanium Dioxide
  • Triethyl Citrate
  • Water

Pharmaceutical Classes:

  • Cyclooxygenase Inhibitors [MoA]
  • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug [EPC]

Related Products:

Based on records with the same trade name.
  • 10544-920 Naproxen 500 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 51655-628 Naproxen Delayed Release 500 mg Oral Tablet, Delayed Release by Northwind Pharmaceuticals
  • 57315-029 Naproxen 375 mg (As Naproxen Sodium 413 mg) Enteric Coated Tablet by Alphapharm Pty. Ltd.
  • 57315-030 Naproxen 500 mg Enteric Coated Tablet by Alphapharm Pty. Ltd.
  • 68788-6322 Naproxen Delayed Release 500 mg Oral Tablet by Preferred Pharmaceuticals Inc.
  • 71335-0245 Naproxen Delayed Release 500 mg Oral Tablet by Bryant Ranch Prepack

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 54569-4520 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.