FDA.reportPublic FDA data

Nicotine

Product NDC
0363-9570
11-digit product format
003639570
Labeler code
0363
Product ID
0363-9570_8f56045b-2d20-45d3-8de6-43914c51d266
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreens
Application
ANDA209206
Marketing category
ANDA
Marketing start
2020-10-30
Marketing end
2027-05-30
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine

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
0363-9570-08Nicotine4 in 1 BOXLOZENGE47
0363-9570-08Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277
0363-9570-24Nicotine24 in 1 BOTTLE, PLASTICLOZENGE247
0363-9570-24Nicotine1 in 1 BOXLOZENGE17
0363-9570-27Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277
0363-9570-27Nicotine1 in 1 BOXLOZENGE17
0363-9570-44Nicotine6 in 1 BOXLOZENGE67
0363-9570-44Nicotine24 in 1 BOTTLE, PLASTICLOZENGE247
0363-9570-72Nicotine3 in 1 BOXLOZENGE37
0363-9570-72Nicotine24 in 1 BOTTLE, PLASTICLOZENGE247

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9570NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS]5Current NDC, Legacy NDC, 10 package rows20221005_25dc2032-4e6a-440a-8327-7b6c877a2430.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN25dc2032-4e6a-440a-8327-7b6c877a24307
359817nicotine 2 MG Oral LozengeSCD25dc2032-4e6a-440a-8327-7b6c877a24307
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY25dc2032-4e6a-440a-8327-7b6c877a24307
359817nicotine 2 MG TrocheSY25dc2032-4e6a-440a-8327-7b6c877a24307

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9570-08003639570084 BOTTLE, PLASTIC in 1 BOX (0363-9570-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-10-302027-05-30NoNoCurrent
0363-9570-24003639570241 BOTTLE, PLASTIC in 1 BOX (0363-9570-24) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-10-302027-05-30NoNoCurrent
0363-9570-27003639570271 BOTTLE, PLASTIC in 1 BOX (0363-9570-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-10-302027-05-30NoNoCurrent
0363-9570-44003639570446 BOTTLE, PLASTIC in 1 BOX (0363-9570-44) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-10-302027-05-30NoNoCurrent
0363-9570-72003639570723 BOTTLE, PLASTIC in 1 BOX (0363-9570-72) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-10-302027-05-30NoNoCurrent