FDA.reportPublic FDA data

Nicotine

Product NDC
0363-0919
11-digit product format
003630919
Labeler code
0363
Product ID
0363-0919_3cd6f7ce-1018-40d5-a5a3-eafbe2d0bea3
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreen Company
Application
ANDA076779
Marketing category
ANDA
Marketing start
2014-03-18
Substance
NICOTINE
Active strength
4 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
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
0363-0919-06Nicotine1 in 1 BLISTER PACKGUM, CHEWING18
0363-0919-06Nicotine160 in 1 CARTONGUM, CHEWING1608
0363-0919-60Nicotine1 in 1 BLISTER PACKGUM, CHEWING18
0363-0919-60Nicotine20 in 1 CARTONGUM, CHEWING208
0363-0919-76Nicotine1 in 1 BLISTER PACKGUM, CHEWING18
0363-0919-76Nicotine120 in 1 CARTONGUM, CHEWING1208
0363-0919-78Nicotine1 in 1 BLISTER PACKGUM, CHEWING18
0363-0919-78Nicotine100 in 1 CARTONGUM, CHEWING1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0919-06EA - Each0363-091995c8d544-7de2-4c6f-ad74-71a492b990d712022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
GELATININACTIVE INGREDIENT2G86QN327LNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QONICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
SORBITOLINACTIVE INGREDIENT506T60A25RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ENICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0919NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]7Current NDC, Legacy NDC, 8 package rows20240817_c44821ba-5c2a-4586-8210-afc02a4031d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNc44821ba-5c2a-4586-8210-afc02a4031d58
311975nicotine 4 MG Chewing GumSCDc44821ba-5c2a-4586-8210-afc02a4031d58
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYc44821ba-5c2a-4586-8210-afc02a4031d58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0919-0600363091906160 BLISTER PACK in 1 CARTON (0363-0919-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2018-01-310000-00-00NoNoCurrent
0363-0919-600036309196020 BLISTER PACK in 1 CARTON (0363-0919-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2014-03-180000-00-00NoNoCurrent
0363-0919-76003630919761 in 1 BLISTER PACKHistorical
0363-0919-7800363091978100 BLISTER PACK in 1 CARTON (0363-0919-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2014-03-180000-00-00NoNoCurrent