NICOTINE

Product NDC
0363-7269
11-digit product format
003637269
Labeler code
0363
Product ID
0363-7269_ebcf227f-597d-449c-9ae5-b505f04261e2
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreen Company
Application
ANDA206394
Marketing category
ANDA
Marketing start
2019-05-24
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
0363-7269-06NICOTINE1 in 1 BLISTER PACKGUM, CHEWING16
0363-7269-06NICOTINE160 in 1 CARTONGUM, CHEWING1606
0363-7269-60NICOTINE20 in 1 CARTONGUM, CHEWING206
0363-7269-60NICOTINE1 in 1 BLISTER PACKGUM, CHEWING16
0363-7269-78NICOTINE1 in 1 BLISTER PACKGUM, CHEWING16
0363-7269-78NICOTINE100 in 1 CARTONGUM, CHEWING1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-7269-78EA - Each0363-72693c575aed-8df5-4c45-8f53-d15a5189911e12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7269NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]5Current NDC, Legacy NDC, 6 package rows20250305_97fefc42-5c9d-453e-a0b6-dc7aac5ee8e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN97fefc42-5c9d-453e-a0b6-dc7aac5ee8e16
314119nicotine 2 MG Chewing GumSCD97fefc42-5c9d-453e-a0b6-dc7aac5ee8e16
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY97fefc42-5c9d-453e-a0b6-dc7aac5ee8e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-7269-0600363726906160 BLISTER PACK in 1 CARTON (0363-7269-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2019-05-280000-00-00NoNoCurrent
0363-7269-600036372696020 BLISTER PACK in 1 CARTON (0363-7269-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2019-05-280000-00-00NoNoCurrent
0363-7269-7800363726978100 BLISTER PACK in 1 CARTON (0363-7269-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2019-05-240000-00-00NoNoCurrent