55111-699 NDC - CETIRIZINE HYDROCHLORIDE

Drug Information

  • Product NDC: 55111-699
  • Proprietary Name:
  • Non Proprietary Name: Cetirizine Hydrochloride
  • Active Ingredient(s): 10 mg/1 CETIRIZINE HYDROCHLORIDE10 mg/1 CETIRIZINE HYDROCHLORIDE
  • Administration Route(s):
  • Dosage Form(s): TABLET, FILM COATED
  • Pharmacy Class(es): Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Dr.Reddy's Laboratories Limited
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:1/10/2010

Package Information

No. Package Code Package Description Billing Unit
155111-699-041 BOTTLE in 1 CARTON (55111-699-04) / 120 TABLET, FILM COATED in 1 BOTTLE
255111-699-151 BLISTER PACK in 1 CARTON (55111-699-15) / 14 TABLET, FILM COATED in 1 BLISTER PACK
355111-699-191 BOTTLE in 1 CARTON (55111-699-19) / 175 TABLET, FILM COATED in 1 BOTTLE
455111-699-301 BOTTLE in 1 CARTON (55111-699-30) / 30 TABLET, FILM COATED in 1 BOTTLE
555111-699-311 BOTTLE in 1 CARTON (55111-699-31) / 300 TABLET, FILM COATED in 1 BOTTLE
655111-699-451 BOTTLE in 1 CARTON (55111-699-45) / 45 TABLET, FILM COATED in 1 BOTTLE
755111-699-472 BOTTLE in 1 CARTON (55111-699-47) / 175 TABLET, FILM COATED in 1 BOTTLE
855111-699-511 BOTTLE in 1 CARTON (55111-699-51) / 75 TABLET, FILM COATED in 1 BOTTLE
955111-699-521 BOTTLE in 1 CARTON (55111-699-52) / 14 TABLET, FILM COATED in 1 BOTTLE
1055111-699-601 BOTTLE in 1 CARTON (55111-699-60) / 60 TABLET, FILM COATED in 1 BOTTLE
1155111-699-731 BOTTLE in 1 CARTON (55111-699-73) / 365 TABLET, FILM COATED in 1 BOTTLE
1255111-699-742 BLISTER PACK in 1 CARTON (55111-699-74) / 7 TABLET, FILM COATED in 1 BLISTER PACK
1355111-699-9090 TABLET, FILM COATED in 1 BOTTLE (55111-699-90)EA
1455111-699-967500 TABLET, FILM COATED in 1 POUCH (55111-699-96)

NDC Record

Field Name Field Value Definition
PRODUCT NDC55111-699The 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.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
NON PROPRIETARY NAMECetirizine HydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE1/15/2008This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NAMEDr.Reddy's Laboratories LimitedName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECETIRIZINE HYDROCHLORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH10 
ACTIVE INGRED UNITmg/1 
PRODUCT NDC55111-699The 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.
PRODUCT TYPE NAMEDRUG FOR FURTHER PROCESSINGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
NON PROPRIETARY NAMECetirizine HydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE1/10/2010This 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 NAMEDr.Reddy's Laboratories LimitedName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECETIRIZINE HYDROCHLORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH10 
ACTIVE INGRED UNITmg/1 

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

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

Previous Code
Next Code