nicotine

Product NDC
79481-1100
11-digit product format
794811100
Labeler code
79481
Product ID
79481-1100_7ecd9a6a-1237-4375-b72c-9f2e30557650
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA077007
Marketing category
ANDA
Marketing start
2023-08-23
Substance
NICOTINE
Active strength
4 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
Listing expiration
2027-12-31

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
79481-1100-0nicotine1 in 1 CARTONLOZENGE14
79481-1100-0nicotine20 in 1 CONTAINERLOZENGE204
79481-1100-1nicotine2 in 1 CARTONLOZENGE24
79481-1100-2nicotine40 in 1 CONTAINERLOZENGE404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-1100NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER, INC.]3Current NDC, 4 package rows20250505_aee78555-7851-46a5-b9fa-c98b46354619.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNaee78555-7851-46a5-b9fa-c98b463546194
359818nicotine 4 MG Oral LozengeSCDaee78555-7851-46a5-b9fa-c98b463546194
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYaee78555-7851-46a5-b9fa-c98b463546194
359818nicotine 4 MG TrocheSYaee78555-7851-46a5-b9fa-c98b463546194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-1100-0794811100001 CONTAINER in 1 CARTON (79481-1100-0) / 20 LOZENGE in 1 CONTAINER1 container2023-09-06NoNoCurrent
79481-1100-1794811100012 CONTAINER in 1 CARTON (79481-1100-1) / 40 LOZENGE in 1 CONTAINER (79481-1100-2) 2 container2023-08-23NoNoCurrent
79481-1100-27948111000240 in 1 CONTAINERHistorical