NDC 54838-101

Silafed

Pseudoephedrine Hydrochloride And Triprolidine Hydrochloride

Silafed is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride.

Product ID54838-101_d0cb36b5-ff55-4145-b295-0614d83fb1c3
NDC54838-101
Product TypeHuman Otc Drug
Proprietary NameSilafed
Generic NamePseudoephedrine Hydrochloride And Triprolidine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date1988-10-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameLannett Company, Inc.
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active Ingredient Strength30 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54838-101-40

118 mL in 1 BOTTLE, PLASTIC (54838-101-40)
Marketing Start Date1988-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54838-101-70 [54838010170]

Silafed SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1988-10-05

NDC 54838-101-40 [54838010140]

Silafed SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1988-10-05

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/5mL

OpenFDA Data

SPL SET ID:b7c62fdd-5709-4023-9c30-6970de4ad2b3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099308
  • UPC Code
  • 0354838101409
  • 0354838101706
  • NDC Crossover Matching brand name "Silafed" or generic name "Pseudoephedrine Hydrochloride And Triprolidine Hydrochloride"

    NDCBrand NameGeneric Name
    54838-101SilafedPseudoephedrine hydrochloride and Triprolidine hydrochloride
    0485-0210ED-A-HIST PSEPSEUDOEPHEDRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE
    58605-305Maxi-Tuss TRPseudoephedrine Hydrochloride and Triprolidine Hydrochloride
    58605-106Maxifed TRpseudoephedrine hydrochloride and triprolidine hydrochloride

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