NDC 69437-416

EC-Naprosyn

Naproxen

EC-Naprosyn is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Canton Laboratories. The primary component is Naproxen.

• Product ID: 69437-416_0aa005eb-b5a2-4f9b-9fa8-0c543a7752b3
• NDC: 69437-416
• Product Type: Human Prescription Drug
• Proprietary Name: EC-Naprosyn
• Generic Name: Naproxen
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-01
• Marketing Category: NDA / NDA
• Application Number: NDA020067
• Labeler Name: Canton Laboratories
• Substance Name: NAPROXEN
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69437-416-01

100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69437-416-01)

• Marketing Start Date: 2016-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69437-416-01 [69437041601]

EC-Naprosyn TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA020067
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-06-01

Drug Details

Active Ingredients

Ingredient	Strength
NAPROXEN	500 mg/1

OpenFDA Data

• SPL SET ID: 8bff5df5-d856-4237-b6a8-ae445b454844
• Manufacturer:
  • Canton Laboratories
• UNII:
  • 57Y76R9ATQ
  • 9TN87S3A3C
• RxNorm Concept Unique ID - RxCUI:
  • 849438
  • 835560
  • 105899
  • 849431
  • 603103
  • 311913
  • 311915
  • 198014
  • 207093
  • 608793
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• UPC Code:
  • 0369437316017
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

Pharmacological Class

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

NDC Crossover Matching brand name "EC-Naprosyn" or generic name "Naproxen"

NDC	Brand Name	Generic Name
0004-6415	EC-Naprosyn	naproxen
69437-415	EC-Naprosyn	EC-Naprosyn
69437-416	EC-Naprosyn	EC-Naprosyn
0363-9609	BACK AND MUSCLE PAIN	NAPROXEN
0121-0899	Naprosyn	Naproxen
0121-1798	Naprosyn	Naproxen
0121-2697	Naprosyn	Naproxen
0054-3630	Naproxen	Naproxen
0093-1005	Naproxen	Naproxen
0093-1006	Naproxen	Naproxen
0143-1346	Naproxen	Naproxen
0143-1347	Naproxen	Naproxen
0143-1348	Naproxen	Naproxen
0179-1978	Naproxen	Naproxen
0440-1852	Naproxen	Naproxen
0440-7852	Naproxen	Naproxen
0615-1504	Naproxen	Naproxen
0615-3562	Naproxen	Naproxen
0615-3563	Naproxen	Naproxen
0615-7709	Naproxen	Naproxen
0615-7892	Naproxen	Naproxen
0615-8094	Naproxen	Naproxen
10544-010	Naproxen	Naproxen
10544-016	Naproxen	Naproxen
10544-019	Naproxen	Naproxen
10544-044	Naproxen	Naproxen
10544-061	Naproxen	Naproxen
10544-111	NAPROXEN	NAPROXEN
10544-277	Naproxen	Naproxen
10544-278	Naproxen	Naproxen
10544-920	Naproxen	Naproxen
10544-922	Naproxen	Naproxen
10544-939	Naproxen	Naproxen
12634-498	Naproxen	Naproxen
12634-684	Naproxen	Naproxen
21695-084	Naproxen	Naproxen
21695-085	Naproxen	Naproxen