NDC 45865-349

Naproxen Sodium

Naproxen Sodium

Naproxen Sodium is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Naproxen Sodium.

• Product ID: 45865-349_7164427d-38b5-6aae-e053-2995a90a0d07
• NDC: 45865-349
• Product Type: Human Prescription Drug
• Proprietary Name: Naproxen Sodium
• Generic Name: Naproxen Sodium
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2007-04-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078432
• Labeler Name: Medsource Pharmaceuticals
• Substance Name: NAPROXEN SODIUM
• Active Ingredient Strength: 550 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: 2019-12-31

Packaging

NDC 45865-349-30

30 TABLET in 1 BOTTLE (45865-349-30)

• Marketing Start Date: 2018-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45865-349-90 [45865034990]

Naproxen Sodium TABLET

• Marketing Category: ANDA
• Application Number: ANDA078432
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-01
• Inactivation Date: 2020-01-31

NDC 45865-349-30 [45865034930]

Naproxen Sodium TABLET

• Marketing Category: ANDA
• Application Number: ANDA078432
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-01
• Inactivation Date: 2020-01-31

NDC 45865-349-60 [45865034960]

Naproxen Sodium TABLET

• Marketing Category: ANDA
• Application Number: ANDA078432
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
NAPROXEN SODIUM	550 mg/1

OpenFDA Data

• SPL SET ID: 7164427d-38b4-6aae-e053-2995a90a0d07
• Manufacturer:
  • Medsource Pharmaceuticals
• UNII:
  • 9TN87S3A3C
• RxNorm Concept Unique ID - RxCUI:
  • 849431

Pharmacological Class

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

NDC Crossover Matching brand name "Naproxen Sodium" or generic name "Naproxen Sodium"

NDC	Brand Name	Generic Name
68016-056	Naproxen Sodium	Naproxen Sodium
68016-661	Naproxen Sodium	Naproxen Sodium
68016-660	Naproxen Sodium	Naproxen Sodium
68071-3054	Naproxen Sodium	Naproxen Sodium
68071-3223	Naproxen Sodium	Naproxen Sodium
68210-0040	NAPROXEN SODIUM	NAPROXEN SODIUM
68210-0400	NAPROXEN SODIUM	NAPROXEN SODIUM
68387-545	Naproxen Sodium	Naproxen Sodium
68462-179	Naproxen Sodium	Naproxen Sodium
68462-178	Naproxen Sodium	Naproxen Sodium
68788-6406	Naproxen Sodium	Naproxen Sodium
68788-7304	Naproxen Sodium	Naproxen Sodium
68788-6934	Naproxen Sodium	Naproxen Sodium
68788-7367	Naproxen Sodium	Naproxen Sodium
68788-9022	Naproxen Sodium	Naproxen Sodium
68998-144	NAPROXEN SODIUM	NAPROXEN SODIUM
68998-145	NAPROXEN SODIUM	NAPROXEN SODIUM
69168-632	Naproxen Sodium	Naproxen Sodium
69230-305	Naproxen Sodium	Naproxen Sodium
69452-179	Naproxen Sodium	Naproxen Sodium
69469-169	Naproxen Sodium	Naproxen Sodium
69842-010	naproxen sodium	naproxen sodium
69842-748	Naproxen Sodium	Naproxen Sodium
69842-417	Naproxen Sodium	Naproxen Sodium
69842-975	Naproxen Sodium	Naproxen Sodium
69842-811	Naproxen Sodium	Naproxen Sodium
70518-0409	Naproxen Sodium	Naproxen Sodium
70518-0178	Naproxen sodium	Naproxen sodium
70518-0724	Naproxen Sodium	Naproxen Sodium
70518-1172	Naproxen Sodium	Naproxen Sodium
71141-116	NAPROXEN SODIUM	NAPROXEN SODIUM
71141-008	Naproxen Sodium	Naproxen Sodium
71335-0274	Naproxen Sodium	Naproxen Sodium
71335-0822	Naproxen Sodium	Naproxen Sodium
71335-1061	Naproxen Sodium	Naproxen Sodium
10544-275	Naproxen Sodium	Naproxen Sodium
10544-128	Naproxen Sodium	Naproxen Sodium
10544-063	Naproxen Sodium	Naproxen Sodium
10544-276	Naproxen Sodium	Naproxen Sodium
11673-175	Naproxen Sodium	Naproxen Sodium
11822-0507	naproxen sodium	naproxen sodium
11673-748	Naproxen Sodium	Naproxen Sodium
11822-0490	naproxen sodium	naproxen sodium
11822-0140	Naproxen Sodium	Naproxen Sodium
21130-174	Naproxen Sodium	Naproxen Sodium
21130-748	Naproxen Sodium	Naproxen Sodium
21695-090	Naproxen Sodium	Naproxen Sodium
17856-0194	Naproxen Sodium	Naproxen Sodium
25000-141	Naproxen Sodium	Naproxen Sodium
25000-144	Naproxen Sodium	Naproxen Sodium