NDC 50580-539

Sudafed 12 Hour Pressure And Pain

Naproxen Sodium And Pseudoephedrine Hydrochloride

Sudafed 12 Hour Pressure And Pain is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consume. The primary component is Naproxen Sodium.

• Product ID: 50580-539_ff4513f0-2263-40d0-b8ec-90237abe35dd
• NDC: 50580-539
• Product Type: Human Otc Drug
• Proprietary Name: Sudafed 12 Hour Pressure And Pain
• Generic Name: Naproxen Sodium And Pseudoephedrine Hydrochloride
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2010-11-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076518
• Labeler Name: Johnson & Johnson Consume
• Substance Name: NAPROXEN SODIUM
• Active Ingredient Strength: 220 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50580-539-16

2 BLISTER PACK in 1 CARTON (50580-539-16) > 8 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2010-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-539-16 [50580053916]

Sudafed 12 Hour Pressure And Pain TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076518
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-11-01
• Marketing End Date: 2018-04-30

Drug Details

Active Ingredients

Ingredient	Strength
NAPROXEN SODIUM	220 mg/1

NDC Crossover Matching brand name "Sudafed 12 Hour Pressure And Pain" or generic name "Naproxen Sodium And Pseudoephedrine Hydrochloride"

NDC	Brand Name	Generic Name
58602-816	Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold	Naproxen Sodium and Pseudoephedrine Hydrochloride
58602-832	Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache	Naproxen Sodium and Pseudoephedrine Hydrochloride
50580-539	Sudafed	Naproxen sodium and Pseudoephedrine Hydrochloride
50580-434	Sudafed Sinus 12 Hour Pressure plus Pain	Naproxen sodium and Pseudoephedrine Hydrochloride