NDC 50580-436

Sudafed PE Head Congestion Plus Pain

Ibuprofen And Phenylephrine Hydrochloride

Sudafed PE Head Congestion Plus Pain is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Ibuprofen; Phenylephrine Hydrochloride.

Product ID50580-436_8ae18c00-8a33-4b28-a901-dd40012f5b14
NDC50580-436
Product TypeHuman Otc Drug
Proprietary NameSudafed PE Head Congestion Plus Pain
Generic NameIbuprofen And Phenylephrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-06-17
Marketing CategoryANDA / ANDA
Application NumberANDA203200
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameIBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength200 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-436-01

2 BLISTER PACK in 1 CARTON (50580-436-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2019-06-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-436-01 [50580043601]

Sudafed PE Head Congestion Plus Pain TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203200
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-06-17

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:76513fb2-7323-4f1f-8a10-92f8f603cf97
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1369775
  • 2173645
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

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