NDC 58809-330

VanaTab AC

Chlophedianol Hcl, Pyrilamine Maleate

VanaTab AC is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc.. The primary component is Pyrilamine Maleate; Chlophedianol Hydrochloride.

Product ID58809-330_4c089fc6-794c-74ef-e054-00144ff8d46c
NDC58809-330
Product TypeHuman Otc Drug
Proprietary NameVanaTab AC
Generic NameChlophedianol Hcl, Pyrilamine Maleate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, Inc.
Substance NamePYRILAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE
Active Ingredient Strength25 mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 58809-330-60

60 TABLET in 1 BOTTLE, PLASTIC (58809-330-60)
Marketing Start Date2017-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-330-60 [58809033060]

VanaTab AC TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-03-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PYRILAMINE MALEATE25 mg/1

OpenFDA Data

SPL SET ID:4b40d8bd-7c79-16f2-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1874721
  • 1941204
  • NDC Crossover Matching brand name "VanaTab AC" or generic name "Chlophedianol Hcl, Pyrilamine Maleate"

    NDCBrand NameGeneric Name
    58809-330VanaTab ACChlophedianol HCl, Pyrilamine Maleate
    58809-221DAYCLEAR ALLERGY RELIEFChlophedianol HCl, Pyrilamine Maleate
    58809-329VanaCof ACChlophedianol HCl, Pyrilamine Maleate

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.