NDC 50580-434

Sudafed Sinus 12 Hour Pressure plus Pain

Naproxen Sodium And Pseudoephedrine Hydrochloride

Sudafed Sinus 12 Hour Pressure plus Pain is a Oral Tablet, Multilayer, Extended Release in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Naproxen Sodium; Pseudoephedrine Hydrochloride.

• Product ID: 50580-434_2e8b6c02-cfc5-4bc4-a646-fcfa9f0d530b
• NDC: 50580-434
• Product Type: Human Otc Drug
• Proprietary Name: Sudafed Sinus 12 Hour Pressure plus Pain
• Generic Name: Naproxen Sodium And Pseudoephedrine Hydrochloride
• Dosage Form: Tablet, Multilayer, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-06-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076518
• Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Substance Name: NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 220 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50580-434-01

2 BLISTER PACK in 1 CARTON (50580-434-01) > 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2019-06-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-434-01 [50580043401]

Sudafed Sinus 12 Hour Pressure plus Pain TABLET, MULTILAYER, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076518
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-17

Drug Details

Active Ingredients

Ingredient	Strength
NAPROXEN SODIUM	220 mg/1

OpenFDA Data

• SPL SET ID: 305adca3-cdae-41e5-a10a-99d9dd0fe390
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 6V9V2RYJ8N
  • 9TN87S3A3C
• RxNorm Concept Unique ID - RxCUI:
  • 1367426
  • 1373034

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

NDC	Brand Name	Generic Name
50580-434	Sudafed Sinus 12 Hour Pressure plus Pain	Naproxen sodium and Pseudoephedrine Hydrochloride
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