Nicotine

Product NDC
0363-7050
11-digit product format
003637050
Labeler code
0363
Product ID
0363-7050_83a5a27e-36a6-4bd9-88e6-4ec510c775a4
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreen Company
Application
ANDA206394
Marketing category
ANDA
Marketing start
2023-06-16
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7050-06Nicotine1 in 1 BLISTER PACKGUM, CHEWING14
0363-7050-06Nicotine160 in 1 CARTONGUM, CHEWING1604
0363-7050-78Nicotine1 in 1 BLISTER PACKGUM, CHEWING14
0363-7050-78Nicotine100 in 1 CARTONGUM, CHEWING1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7050NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3Current NDC, 4 package rows20250207_7446369d-2fac-4c5a-a6bb-9e149abc4c15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN7446369d-2fac-4c5a-a6bb-9e149abc4c154
314119nicotine 2 MG Chewing GumSCD7446369d-2fac-4c5a-a6bb-9e149abc4c154
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY7446369d-2fac-4c5a-a6bb-9e149abc4c154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-7050-0600363705006160 BLISTER PACK in 1 CARTON (0363-7050-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2023-06-16NoNoHistorical
0363-7050-78003637050781 in 1 BLISTER PACKHistorical