FDA.reportPublic FDA data

Nicotine

Product NDC
0363-9590
11-digit product format
003639590
Labeler code
0363
Product ID
0363-9590_22be9a90-9024-43fc-a56d-eacb6f29a310
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreens
Application
ANDA210712
Marketing category
ANDA
Marketing start
2021-05-28
Marketing end
2027-05-28
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
0363-9590-08Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277
0363-9590-08Nicotine4 in 1 BOXLOZENGE47
0363-9590-24Nicotine24 in 1 BOTTLE, PLASTICLOZENGE247
0363-9590-24Nicotine1 in 1 BOXLOZENGE17
0363-9590-27Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277
0363-9590-27Nicotine1 in 1 BOXLOZENGE17
0363-9590-72Nicotine24 in 1 BOTTLE, PLASTICLOZENGE247
0363-9590-72Nicotine3 in 1 BOXLOZENGE37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9590NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS]6Current NDC, Legacy NDC, 8 package rows20230805_0135caa0-f5e9-471e-ac5f-6b9be8ddfcb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN0135caa0-f5e9-471e-ac5f-6b9be8ddfcb07
359817nicotine 2 MG Oral LozengeSCD0135caa0-f5e9-471e-ac5f-6b9be8ddfcb07
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY0135caa0-f5e9-471e-ac5f-6b9be8ddfcb07
359817nicotine 2 MG TrocheSY0135caa0-f5e9-471e-ac5f-6b9be8ddfcb07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9590-08003639590084 BOTTLE, PLASTIC in 1 BOX (0363-9590-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC2021-05-282027-05-28NoNoCurrent
0363-9590-24003639590241 BOTTLE, PLASTIC in 1 BOX (0363-9590-24) / 24 LOZENGE in 1 BOTTLE, PLASTIC2021-05-282027-05-28NoNoCurrent
0363-9590-27003639590271 BOTTLE, PLASTIC in 1 BOX (0363-9590-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC2021-05-282027-05-28NoNoCurrent
0363-9590-72003639590723 BOTTLE, PLASTIC in 1 BOX (0363-9590-72) / 24 LOZENGE in 1 BOTTLE, PLASTIC2021-05-282027-05-28NoNoCurrent