nicotine

Product NDC
11822-0201
11-digit product format
118220201
Labeler code
11822
Product ID
11822-0201_af7ead83-1934-44e3-9535-5205dab67118
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA090821
Marketing category
ANDA
Marketing start
2020-12-11
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
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
11822-0201-0nicotine3 in 1 CARTONLOZENGE33
11822-0201-0nicotine24 in 1 CONTAINERLOZENGE243
11822-0201-1nicotine24 in 1 CONTAINERLOZENGE243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0201NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]3Current NDC, Legacy NDC, 3 package rows20231207_cd17f3b4-dddd-4387-9fb1-1efa32ba1d2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNcd17f3b4-dddd-4387-9fb1-1efa32ba1d2b3
359817nicotine 2 MG Oral LozengeSCDcd17f3b4-dddd-4387-9fb1-1efa32ba1d2b3
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYcd17f3b4-dddd-4387-9fb1-1efa32ba1d2b3
359817nicotine 2 MG TrocheSYcd17f3b4-dddd-4387-9fb1-1efa32ba1d2b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0201-0118220201003 CONTAINER in 1 CARTON (11822-0201-0) / 24 LOZENGE in 1 CONTAINER3 container2020-12-110000-00-00NoNoCurrent
11822-0201-11182202010124 LOZENGE in 1 CONTAINER (11822-0201-1) 24 lozenge2020-12-11NoNoCurrent