78501-4000 NDC - BV BYE VIRUS 99 ()

Drug Information

  • Product NDC: 78501-4000
  • Proprietary Name: BV BYE VIRUS 99
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: COMERCIAL GOURA,S. DE R.L.
Product Type:
FDA Application Number: part333A
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:6/29/2020

Package Information

No. Package Code Package Description Billing Unit
178501-4000-119000 mL in 1 PAIL (78501-4000-1)
278501-4000-24000 mL in 1 JUG (78501-4000-2)
378501-4000-460 mL in 1 BOTTLE (78501-4000-4)
478501-4000-530 mL in 1 BOTTLE (78501-4000-5)
578501-4000-6125 mL in 1 BOTTLE (78501-4000-6)
678501-4000-7250 mL in 1 BOTTLE (78501-4000-7)
778501-4000-8500 mL in 1 BOTTLE (78501-4000-8)
878501-4000-91000 mL in 1 BOTTLE (78501-4000-9)

NDC Record

Field Name Field Value Definition
PRODUCT NDC78501-4000The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEBV BYE VIRUS 99The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE6/29/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERpart333AThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECOMERCIAL GOURA,S. DE R.L.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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