Nicotine

Product NDC
0363-3911
11-digit product format
003633911
Labeler code
0363
Product ID
0363-3911_c6eab86c-99d8-424c-b4a2-6be56cf6d603
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreens
Application
ANDA079219
Marketing category
ANDA
Marketing start
2020-10-30
Substance
NICOTINE
Active strength
4 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
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975

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
0363-3911-10Nicotine100 in 1 CARTONGUM, CHEWING1005
0363-3911-10Nicotine1 in 1 BLISTER PACKGUM, CHEWING15
0363-3911-16Nicotine160 in 1 CARTONGUM, CHEWING1605
0363-3911-16Nicotine1 in 1 BLISTER PACKGUM, CHEWING15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3911NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREENS]5Current NDC, Legacy NDC, 4 package rows20221007_d933d32c-cb4a-41b2-9563-da74cf2d77e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNd933d32c-cb4a-41b2-9563-da74cf2d77e45
311975nicotine 4 MG Chewing GumSCDd933d32c-cb4a-41b2-9563-da74cf2d77e45
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYd933d32c-cb4a-41b2-9563-da74cf2d77e45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-3911-1000363391110100 BLISTER PACK in 1 CARTON (0363-3911-10) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2020-10-300000-00-00NoNoCurrent
0363-3911-1600363391116160 BLISTER PACK in 1 CARTON (0363-3911-16) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2020-10-300000-00-00NoNoCurrent