FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
45802-344
11-digit product format
458020344
Labeler code
45802
Product ID
45802-344_ca48c382-aaff-4265-adf6-cc945b6a9266
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA077007
Marketing category
ANDA
Marketing start
2014-03-31
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Polacrilex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-344-05Nicotine Polacrilex24 in 1 CONTAINERLOZENGE245
45802-344-05Nicotine Polacrilex3 in 1 CARTONLOZENGE35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-344-05EA - Each45802-344a9b6a1f2-7ffb-4620-8aa4-28ad1a3d354912014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1NICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-344NICOTINE POLACRILEX LOZENGE [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 2 package rows20250119_157e5479-28d6-4493-a8cf-597b9e5622c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN6c814edf-0917-4e48-8d26-931b1db2788014
359817nicotine 2 MG Oral LozengeSCD6c814edf-0917-4e48-8d26-931b1db2788014
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY6c814edf-0917-4e48-8d26-931b1db2788014
359817nicotine 2 MG TrocheSY6c814edf-0917-4e48-8d26-931b1db2788014
359817nicotine 2 MG Oral LozengePSN157e5479-28d6-4493-a8cf-597b9e5622c05
359817nicotine 2 MG Oral LozengeSCD157e5479-28d6-4493-a8cf-597b9e5622c05
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY157e5479-28d6-4493-a8cf-597b9e5622c05
359817nicotine 2 MG TrocheSY157e5479-28d6-4493-a8cf-597b9e5622c05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-344-05458020344053 CONTAINER in 1 CARTON (45802-344-05) / 24 LOZENGE in 1 CONTAINER3 container2014-03-310000-00-00NoNoCurrent