NDC 0573-2952

PRIMATENE

Ephedrine Hcl, Guaifenesin

PRIMATENE is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Wyeth Consumer Healthcare Llc. The primary component is Ephedrine Hydrochloride; Guaifenesin.

Product ID0573-2952_4c359434-9f46-45c6-93c6-15091629ee07
NDC0573-2952
Product TypeHuman Otc Drug
Proprietary NamePRIMATENE
Generic NameEphedrine Hcl, Guaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2004-01-06
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameWyeth Consumer Healthcare LLC
Substance NameEPHEDRINE HYDROCHLORIDE; GUAIFENESIN
Active Ingredient Strength13 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0573-2952-10

2 BLISTER PACK in 1 CARTON (0573-2952-10) > 12 TABLET in 1 BLISTER PACK
Marketing Start Date2004-01-06
Marketing End Date2023-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0573-2952-10 [00573295210]

PRIMATENE TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2004-01-06

NDC 0573-2952-20 [00573295220]

PRIMATENE TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2004-01-06

Drug Details

Active Ingredients

IngredientStrength
EPHEDRINE HYDROCHLORIDE12.5 mg/1

OpenFDA Data

SPL SET ID:9005482c-25ae-d365-33d1-29269532c74d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1115991
  • 1116102
  • NDC Crossover Matching brand name "PRIMATENE" or generic name "Ephedrine Hcl, Guaifenesin"

    NDCBrand NameGeneric Name
    0573-2952PRIMATENEephedrine HCl, guaifenesin
    80070-600PrimateneEPHEDRINE HYDROCHLORIDE
    0363-2529Bronchial Asthma ReliefEphedrine HCl, Guaifenesin
    0363-7430Bronchial Asthma ReliefEphedrine HCl, Guaifenesin

    Trademark Results [PRIMATENE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRIMATENE
    PRIMATENE
    88202829 5841251 Live/Registered
    ARMSTRONG PHARMACEUTICALS, INC.
    2018-11-21
    PRIMATENE
    PRIMATENE
    71670640 0608592 Live/Registered
    WHITEHALL PHARMACAL COMPANY
    1954-07-26

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