NDC 69784-501

EC-NAPROXEN

Naproxen

EC-NAPROXEN is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Woodward Pharma Services Llc. The primary component is Naproxen.

• Product ID: 69784-501_3cf69408-c2d6-453f-ab49-3007f220dd70
• NDC: 69784-501
• Product Type: Human Prescription Drug
• Proprietary Name: EC-NAPROXEN
• Generic Name: Naproxen
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-15
• Marketing Category: NDA / NDA
• Application Number: NDA020067
• Labeler Name: Woodward Pharma Services LLC
• Substance Name: NAPROXEN
• Active Ingredient Strength: 375 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: 2021-12-31

Packaging

NDC 69784-501-01

100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69784-501-01)

• Marketing Start Date: 2018-10-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69784-501-01 [69784050101]

EC-NAPROXEN TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA020067
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-15

Drug Details

Active Ingredients

Ingredient	Strength
NAPROXEN	375 mg/1

OpenFDA Data

• SPL SET ID: 0728935b-19fc-4a10-aeba-29c42ce7f472
• Manufacturer:
  • Woodward Pharma Services LLC
• UNII:
  • 57Y76R9ATQ
  • 9TN87S3A3C
• RxNorm Concept Unique ID - RxCUI:
  • 849431
  • 603103
  • 311915
  • 198014
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• UPC Code:
  • 0369784505010
  • 0369784501012
  • 0369784500015
  • 0369784550010
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]

Medicade Reported Pricing

69784050101 EC-NAPROXEN DR 375 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
69784-500	EC-NAPROXEN	EC-NAPROXEN
69784-501	EC-NAPROXEN	EC-NAPROXEN
42494-407	EC-NAPROXEN	EC-NAPROXEN
42494-408	EC-NAPROXEN	EC-NAPROXEN
0363-9609	BACK AND MUSCLE PAIN	NAPROXEN
0004-6415	EC-Naprosyn	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