Nicotine

Product NDC
0363-9610
11-digit product format
003639610
Labeler code
0363
Product ID
0363-9610_dea41898-912e-45e1-85a6-e637e74dea1d
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreens
Application
ANDA212056
Marketing category
ANDA
Marketing start
2021-05-28
Marketing end
2027-02-15
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9610-24Nicotine24 in 1 BOTTLE, PLASTICLOZENGE244
0363-9610-24Nicotine1 in 1 BOXLOZENGE14
0363-9610-72Nicotine24 in 1 BOTTLE, PLASTICLOZENGE244
0363-9610-72Nicotine3 in 1 BOXLOZENGE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9610NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS]3Current NDC, Legacy NDC, 4 package rows20220929_902c6ae5-971b-427c-b311-5a051b98a53d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN902c6ae5-971b-427c-b311-5a051b98a53d4
359817nicotine 2 MG Oral LozengeSCD902c6ae5-971b-427c-b311-5a051b98a53d4
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY902c6ae5-971b-427c-b311-5a051b98a53d4
359817nicotine 2 MG TrocheSY902c6ae5-971b-427c-b311-5a051b98a53d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9610-24003639610241 BOTTLE, PLASTIC in 1 BOX (0363-9610-24) / 24 LOZENGE in 1 BOTTLE, PLASTIC2021-05-282027-02-15NoNoCurrent
0363-9610-72003639610723 BOTTLE, PLASTIC in 1 BOX (0363-9610-72) / 24 LOZENGE in 1 BOTTLE, PLASTIC2021-05-282027-02-15NoNoCurrent