43598-486 NDC - NICOTINE POLACRILEX

Drug Information

Product NDC: 43598-486

Proprietary Name: Nicotine Polacrilex

Non Proprietary Name: Nicotine Polacrilex

Active Ingredient(s):
  • 2 mg/1 NICOTINE


Administration Route(s): ORAL

Dosage Form(s): LOZENGE

Pharmacy Class(es):
  • Cholinergic Nicotinic Agonist [EPC];
  • Nicotine [CS]

Labeler Information

Labeler Name: Dr. Reddy's Laboratories Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA212796
Marketing Category: ANDA
Start Marketing Date:6/9/2020

Package Information

No. Package Code Package Description Billing Unit
143598-486-104 BOTTLE in 1 CARTON (43598-486-10) / 27 LOZENGE in 1 BOTTLEEA
243598-486-125 BOTTLE in 1 CARTON (43598-486-12) / 24 LOZENGE in 1 BOTTLE
343598-486-135 BOTTLE in 1 CARTON (43598-486-13) / 27 LOZENGE in 1 BOTTLE
443598-486-146 BOTTLE in 1 CARTON (43598-486-14) / 24 LOZENGE in 1 BOTTLE
543598-486-166 BOTTLE in 1 CARTON (43598-486-16) / 27 LOZENGE in 1 BOTTLE
643598-486-177 BOTTLE in 1 CARTON (43598-486-17) / 24 LOZENGE in 1 BOTTLE
743598-486-187 BOTTLE in 1 CARTON (43598-486-18) / 27 LOZENGE in 1 BOTTLE
843598-486-198 BOTTLE in 1 CARTON (43598-486-19) / 24 LOZENGE in 1 BOTTLE
943598-486-2210 BOTTLE in 1 CARTON (43598-486-22) / 24 LOZENGE in 1 BOTTLE
1043598-486-238 BOTTLE in 1 CARTON (43598-486-23) / 27 LOZENGE in 1 BOTTLE
1143598-486-241 BOTTLE in 1 CARTON (43598-486-24) / 24 LOZENGE in 1 BOTTLEEA
1243598-486-271 BOTTLE in 1 CARTON (43598-486-27) / 27 LOZENGE in 1 BOTTLEEA
1343598-486-2910 BOTTLE in 1 CARTON (43598-486-29) / 27 LOZENGE in 1 BOTTLE
1443598-486-482 BOTTLE in 1 CARTON (43598-486-48) / 24 LOZENGE in 1 BOTTLE
1543598-486-542 BOTTLE in 1 CARTON (43598-486-54) / 27 LOZENGE in 1 BOTTLE
1643598-486-723 BOTTLE in 1 CARTON (43598-486-72) / 24 LOZENGE in 1 BOTTLEEA
1743598-486-737 BOTTLE in 1 CARTON (43598-486-73) / 24 LOZENGE in 1 BOTTLE
1843598-486-747 BOTTLE in 1 CARTON (43598-486-74) / 27 LOZENGE in 1 BOTTLE
1943598-486-813 BOTTLE in 1 CARTON (43598-486-81) / 27 LOZENGE in 1 BOTTLEEA
2043598-486-964 BOTTLE in 1 CARTON (43598-486-96) / 24 LOZENGE in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC43598-486The 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 NAMENicotine PolacrilexThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMENicotine PolacrilexThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELOZENGEThe 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 DATE6/9/2020This 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 NUMBERANDA212796This 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 Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMENICOTINEAn 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 STRENGTH2 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESCholinergic Nicotinic Agonist [EPC], Nicotine [CS] 

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