nicotine

Product NDC
11822-0009
11-digit product format
118220009
Labeler code
11822
Product ID
11822-0009_a33c9055-b95b-4c97-8739-c11a699683cf
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA090711
Marketing category
ANDA
Marketing start
2015-02-05
Marketing end
2026-10-31
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

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
11822-0009-1nicotine24 in 1 CONTAINERLOZENGE244
11822-0009-1nicotine3 in 1 CARTONLOZENGE34

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0009NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]4Current NDC, Legacy NDC, 2 package rows20230712_f1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNf1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c5
359818nicotine 4 MG Oral LozengeSCDf1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c5
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYf1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c5
359818nicotine 4 MG TrocheSYf1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0009-1118220009013 CONTAINER in 1 CARTON (11822-0009-1) / 24 LOZENGE in 1 CONTAINER3 container2015-02-050000-00-00NoNoCurrent