Nicotine

Product NDC
0363-5760
11-digit product format
003635760
Labeler code
0363
Product ID
0363-5760_fe6db784-e246-4065-baff-34a5390bd047
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreens
Application
ANDA210711
Marketing category
ANDA
Marketing start
2021-03-26
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5760-20Nicotine1 in 1 BOXLOZENGE15
0363-5760-20Nicotine20 in 1 BOTTLE, PLASTICLOZENGE205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5760NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS]5Current NDC, Legacy NDC, 2 package rows20240222_19bd0eb4-0cd6-4979-bef6-eedbd4d5de88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN19bd0eb4-0cd6-4979-bef6-eedbd4d5de885
359817nicotine 2 MG Oral LozengeSCD19bd0eb4-0cd6-4979-bef6-eedbd4d5de885
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY19bd0eb4-0cd6-4979-bef6-eedbd4d5de885
359817nicotine 2 MG TrocheSY19bd0eb4-0cd6-4979-bef6-eedbd4d5de885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-5760-20003635760201 BOTTLE, PLASTIC in 1 BOX (0363-5760-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC2021-03-260000-00-00NoNoCurrent