68210-0116 NDC - GUAIFENESIN

Drug Information

  • Product NDC: 68210-0116
  • Proprietary Name:
  • Non Proprietary Name: Guaifenesin
  • Active Ingredient(s): 400 mg/1 GUAIFENESIN
  • Administration Route(s):
  • Dosage Form(s): TABLET

Labeler Information

Field Name Field Value
Labeler Name: SPIRIT PHARMACEUTICALS LLC
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:3/2/2018

Package Information

No. Package Code Package Description Billing Unit
168210-0116-01 BAG in 1 DRUM (68210-0116-0) / 30000 TABLET in 1 BAG
268210-0116-11 BOTTLE in 1 CARTON (68210-0116-1) / 15 TABLET in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC68210-0116The 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.
START MARKETING DATE3/15/2018This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH 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.
LABELER NAMESPIRIT PHARMACEUTICALS LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC68210-0116The 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.
START MARKETING DATE3/2/2018This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGProduct 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.
LABELER NAMESPIRIT PHARMACEUTICALS LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 7/4/2025

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