NDC 0280-6045

Aleve-D Sinus and Headache

Naproxen Sodium, Pseudoephedrine Hydrochloride

Aleve-D Sinus and Headache is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Naproxen Sodium; Pseudoephedrine Hydrochloride.

Product ID0280-6045_5ab980c0-c48b-233b-e053-2991aa0a4fd1
NDC0280-6045
Product TypeHuman Otc Drug
Proprietary NameAleve-D Sinus and Headache
Generic NameNaproxen Sodium, Pseudoephedrine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA076518
Labeler NameBayer HealthCare LLC.
Substance NameNAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength220 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0280-6045-10

1 BLISTER PACK in 1 CARTON (0280-6045-10) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0280-6045-10 [00280604510]

Aleve-D Sinus and Headache TABLET
Marketing CategoryANDA
Application NumberANDA076518
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-01

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM220 mg/1

OpenFDA Data

SPL SET ID:5ab980c0-c48a-233b-e053-2991aa0a4fd1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1367426
  • 1367428
  • UPC Code
  • 0325866569516
  • NDC Crossover Matching brand name "Aleve-D Sinus and Headache" or generic name "Naproxen Sodium, Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    0280-6045Aleve-D Sinus and Headachenaproxen sodium, pseudoephedrine hydrochloride
    49035-792equate sinus and cold dnaproxen sodium, pseudoephedrine hydrochloride

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