Nicotine Polacrilex

Product NDC
50090-1154
11-digit product format
500901154
Labeler code
50090
Product ID
50090-1154_16c993b9-9897-4914-b124-8107e05bfc38
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
4 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
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359818

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
50090-1154-0Nicotine Polacrilex24 in 1 CONTAINERLOZENGE2412
50090-1154-0Nicotine Polacrilex3 in 1 CARTONLOZENGE312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1154-0EA - Each50090-11549ef3e346-0956-4ffd-85aa-d7fa501e933212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1154NICOTINE POLACRILEX LOZENGE [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20231210_bee5365b-e7f1-493a-baec-8604bd5550e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNbee5365b-e7f1-493a-baec-8604bd5550e312
359818nicotine 4 MG Oral LozengeSCDbee5365b-e7f1-493a-baec-8604bd5550e312
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYbee5365b-e7f1-493a-baec-8604bd5550e312
359818nicotine 4 MG TrocheSYbee5365b-e7f1-493a-baec-8604bd5550e312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1154-0500901154003 CONTAINER in 1 CARTON (50090-1154-0) / 24 LOZENGE in 1 CONTAINER3 container2014-11-280000-00-00NoNoCurrent