76168-501 NDC - ALLERGY RELIEF 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE)

Drug Information

Product NDC: 76168-501

Proprietary Name: Allergy Relief 24HR

Non Proprietary Name: Levocetirizine dihydrochloride

Active Ingredient(s):
  • 5 mg/1 LEVOCETIRIZINE DIHYDROCHLORIDE


Administration Route(s): ORAL

Dosage Form(s): TABLET

Pharmacy Class(es):
  • Histamine H1 Receptor Antagonists [MoA];
  • Histamine-1 Receptor Antagonist [EPC]

Labeler Information

Labeler Name: VELOCITY PHARMA LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA211551
Marketing Category: ANDA
Start Marketing Date:7/2/2019

Package Information

No. Package Code Package Description Billing Unit
176168-501-101 BOTTLE in 1 CARTON (76168-501-10) / 10 TABLET in 1 BOTTLE
276168-501-111 BOTTLE in 1 CARTON (76168-501-11) / 100 TABLET in 1 BOTTLE
376168-501-181 BOTTLE in 1 CARTON (76168-501-18) / 180 TABLET in 1 BOTTLE
476168-501-241 BOTTLE in 1 CARTON (76168-501-24) / 240 TABLET in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC76168-501The 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 NAMEAllergy Relief 24HRThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMELevocetirizine dihydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe 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 DATE7/2/2019This 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 NUMBERANDA211551This 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 NAMEVELOCITY PHARMA LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMELEVOCETIRIZINE DIHYDROCHLORIDEAn 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 STRENGTH5 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] 

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This page was last updated on: 2/1/2023