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 ID50580-434_2e8b6c02-cfc5-4bc4-a646-fcfa9f0d530b
NDC50580-434
Product TypeHuman Otc Drug
Proprietary NameSudafed Sinus 12 Hour Pressure plus Pain
Generic NameNaproxen Sodium And Pseudoephedrine Hydrochloride
Dosage FormTablet, Multilayer, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-06-17
Marketing CategoryANDA / ANDA
Application NumberANDA076518
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameNAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength220 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

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 Date2019-06-17
NDC Exclude FlagN
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 CategoryANDA
Application NumberANDA076518
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-06-17

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM220 mg/1

OpenFDA Data

SPL SET ID:305adca3-cdae-41e5-a10a-99d9dd0fe390
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    50580-434Sudafed Sinus 12 Hour Pressure plus PainNaproxen sodium and Pseudoephedrine Hydrochloride
    58602-816Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and ColdNaproxen Sodium and Pseudoephedrine Hydrochloride
    58602-832Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and HeadacheNaproxen Sodium and Pseudoephedrine Hydrochloride
    50580-539SudafedNaproxen sodium and Pseudoephedrine Hydrochloride

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