FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
45802-089
11-digit product format
458020089
Labeler code
45802
Product ID
45802-089_b0db32b2-4ace-4fbe-a319-029ce7d54251
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA203690
Marketing category
ANDA
Marketing start
2016-07-08
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Polacrilex
Listing expiration
2027-12-31

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
45802-089-01Nicotine Polacrilex27 in 1 CONTAINERLOZENGE274
45802-089-02Nicotine Polacrilex3 in 1 CARTONLOZENGE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-089NICOTINE POLACRILEX LOZENGE [PADAGIS ISRAEL PHARMACEUTICALS LTD]3Current NDC, Legacy NDC, 2 package rows20250228_b765570e-e5b5-48e4-b4d2-2a85ac19a2ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNc2627853-945b-42d8-8351-39028e513d77100
359817nicotine 2 MG Oral LozengeSCDc2627853-945b-42d8-8351-39028e513d77100
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYc2627853-945b-42d8-8351-39028e513d77100
359817nicotine 2 MG TrocheSYc2627853-945b-42d8-8351-39028e513d77100
359817nicotine 2 MG Oral LozengePSNb765570e-e5b5-48e4-b4d2-2a85ac19a2ea4
359817nicotine 2 MG Oral LozengeSCDb765570e-e5b5-48e4-b4d2-2a85ac19a2ea4
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYb765570e-e5b5-48e4-b4d2-2a85ac19a2ea4
359817nicotine 2 MG TrocheSYb765570e-e5b5-48e4-b4d2-2a85ac19a2ea4
359817nicotine 2 MG Oral LozengePSN094de23b-d433-487d-8364-6f245c8117c62
359817nicotine 2 MG Oral LozengeSCD094de23b-d433-487d-8364-6f245c8117c62
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY094de23b-d433-487d-8364-6f245c8117c62
359817nicotine 2 MG TrocheSY094de23b-d433-487d-8364-6f245c8117c62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-089-014580200890127 in 1 CONTAINERHistorical
45802-089-02458020089023 CONTAINER in 1 CARTON (45802-089-02) / 27 LOZENGE in 1 CONTAINER (45802-089-01) 3 container2016-07-080000-00-00NoNoCurrent