55111-699 NDC - CETIRIZINE HYDROCHLORIDE

Drug Information

Product NDC: 55111-699

Proprietary Name: Cetirizine Hydrochloride

Non Proprietary Name: Cetirizine Hydrochloride

Active Ingredient(s):
  • 10 mg/1 CETIRIZINE HYDROCHLORIDE


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

Labeler Information

Labeler Name: Dr.Reddy's Laboratories Limited
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA078343
Marketing Category: ANDA
Start Marketing Date:1/15/2008

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
1355111-699-901 BOTTLE in 1 CARTON (55111-699-90) > 90 TABLET, FILM COATED in 1 BOTTLEEA

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.
PROPRIETARY NAMECetirizine HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
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.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
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.
APPLICATION NUMBERANDA078343This 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 NAMEDr.Reddy's Laboratories LimitedName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECETIRIZINE HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH10 
ACTIVE INGRED UNITmg/1 

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This page was last updated on: 8/16/2021