NDC 55289-307

Naproxen

Naproxen

Naproxen is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Naproxen.

• Product ID: 55289-307_7c1ebf5a-0b5d-dd0f-e053-2991aa0a1296
• NDC: 55289-307
• Product Type: Human Prescription Drug
• Proprietary Name: Naproxen
• Generic Name: Naproxen
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 1998-07-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075227
• Labeler Name: PD-Rx Pharmaceuticals, Inc.
• Substance Name: NAPROXEN
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55289-307-60

60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-307-60)

• Marketing Start Date: 2010-09-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-307-24 [55289030724]

Naproxen TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075227
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-09-23
• Marketing End Date: 2019-09-11

NDC 55289-307-15 [55289030715]

Naproxen TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075227
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-09-23
• Marketing End Date: 2019-09-11

NDC 55289-307-60 [55289030760]

Naproxen TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075227
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-09-23
• Marketing End Date: 2019-09-11

NDC 55289-307-30 [55289030730]

Naproxen TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075227
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-09-23
• Marketing End Date: 2019-09-11

Drug Details

Active Ingredients

Ingredient	Strength
NAPROXEN	500 mg/1

OpenFDA Data

• SPL SET ID: 779277af-dcd9-45b5-adeb-2cfdf3c001de
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • 57Y76R9ATQ
• RxNorm Concept Unique ID - RxCUI:
  • 311915
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• UPC Code:
  • 0355289307150
• 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 "Naproxen" or generic name "Naproxen"

NDC	Brand Name	Generic Name
0054-3630	Naproxen	Naproxen
0093-1005	Naproxen	Naproxen
0093-1006	Naproxen	Naproxen
0143-1346	Naproxen	Naproxen
0143-1347	Naproxen	Naproxen
0143-1348	Naproxen	Naproxen
0143-9908	NAPROXEN	naproxen sodium
0143-9916	NAPROXEN	naproxen sodium
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
10544-614	NAPROXEN	naproxen sodium
10544-920	Naproxen	Naproxen
10544-922	Naproxen	Naproxen
10544-939	Naproxen	Naproxen
12634-498	Naproxen	Naproxen
68071-3092	Naproxen	Naproxen
68071-4006	NAPROXEN	NAPROXEN
68071-3029	naproxen	naproxen
68071-3066	naproxen	naproxen
68071-3387	Naproxen	Naproxen
68071-3345	NAPROXEN	NAPROXEN
68071-4510	NAPROXEN	NAPROXEN
68071-4381	NAPROXEN	NAPROXEN
68134-201	Naproxen	Naproxen
68151-2894	Naproxen	Naproxen
68151-2609	Naproxen	Naproxen
68151-2895	Naproxen	Naproxen
68382-012	Naproxen	Naproxen
68382-013	Naproxen	Naproxen
68382-014	Naproxen	Naproxen
68387-800	Naproxen	Naproxen
68387-801	Naproxen	Naproxen
68387-802	Naproxen	Naproxen
68462-190	Naproxen	Naproxen
68462-189	Naproxen	Naproxen