Nicotine Polacrilex

Product NDC
50090-1152
11-digit product format
500901152
Labeler code
50090
Product ID
50090-1152_6a2cc472-3f64-4548-beb7-56ee0e2d260a
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
A-S Medication Solutions
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1152-0Nicotine Polacrilex24 in 1 CONTAINERLOZENGE2414
50090-1152-0Nicotine Polacrilex3 in 1 CARTONLOZENGE314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1152-0EA - Each50090-1152e64db5d0-2bfa-4a1b-8997-1ca4dd2cfdb512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1152NICOTINE POLACRILEX LOZENGE [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 2 package rows20231210_6c814edf-0917-4e48-8d26-931b1db27880.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1152-0500901152003 CONTAINER in 1 CARTON (50090-1152-0) / 24 LOZENGE in 1 CONTAINER3 container2014-11-280000-00-00NoNoCurrent