Nicotine Polacrilex

Product NDC
0363-1608
11-digit product format
003631608
Labeler code
0363
Product ID
0363-1608_ce202975-a51b-43ae-aec6-d64f38f1be16
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreens
Application
ANDA074507
Marketing category
ANDA
Marketing start
2014-01-01
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 Polacrilex
Brand name suffix
original
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975, 314119

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
0363-1608-62Nicotine Polacrilexoriginal1 in 1 BLISTER PACKGUM, CHEWING112
0363-1608-62Nicotine Polacrilexoriginal110 in 1 CARTONGUM, CHEWING11012
0363-1608-98Nicotine Polacrilexoriginal1 in 1 BLISTER PACKGUM, CHEWING112
0363-1608-98Nicotine Polacrilexoriginal170 in 1 CARTONGUM, CHEWING17012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1608NICOTINE POLACRILEX ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [WALGREENS]8Current NDC, Legacy NDC, 4 package rows20241018_f759d9b2-35e0-4b88-9219-4c0e483af5c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNf759d9b2-35e0-4b88-9219-4c0e483af5c412
311975nicotine polacrilex 4 MG Chewing GumPSNf759d9b2-35e0-4b88-9219-4c0e483af5c412
314119nicotine 2 MG Chewing GumSCDf759d9b2-35e0-4b88-9219-4c0e483af5c412
311975nicotine 4 MG Chewing GumSCDf759d9b2-35e0-4b88-9219-4c0e483af5c412
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYf759d9b2-35e0-4b88-9219-4c0e483af5c412
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYf759d9b2-35e0-4b88-9219-4c0e483af5c412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1608-6200363160862110 BLISTER PACK in 1 CARTON (0363-1608-62) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2014-01-010000-00-00NoNoCurrent
0363-1608-9800363160898170 BLISTER PACK in 1 CARTON (0363-1608-98) / 1 GUM, CHEWING in 1 BLISTER PACK170 blister pack2014-01-010000-00-00NoNoCurrent