NDC 42254-359

nasal decongestant

Pseudoephedrine Hydrochloride

nasal decongestant is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Pseudoephedrine Hydrochloride.

Product ID42254-359_83ae6177-afbb-477f-a5ff-64d48960ffef
NDC42254-359
Product TypeHuman Otc Drug
Proprietary Namenasal decongestant
Generic NamePseudoephedrine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date1999-08-12
Marketing CategoryANDA / ANDA
Application NumberANDA075153
Labeler NameRebel Distributors Corp
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength120 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 42254-359-10

1 BLISTER PACK in 1 CARTON (42254-359-10) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date1999-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42254-359-10 [42254035910]

nasal decongestant TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075153
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1999-08-12
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

OpenFDA Data

SPL SET ID:83ae6177-afbb-477f-a5ff-64d48960ffef
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049154

    • NDC Crossover Matching brand name "nasal decongestant" or generic name "Pseudoephedrine Hydrochloride"

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