FDA.reportPublic FDA data

up and up uncoated nicotine

Product NDC
82442-029
11-digit product format
824420029
Labeler code
82442
Product ID
82442-029_49669b0a-c98c-4477-8e14-cba945c6f3a5
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Target Corporation
Application
ANDA076775
Marketing category
ANDA
Marketing start
2024-05-14
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
up and up uncoated 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
82442-029-02up and up uncoated nicotine1 in 1 BLISTER PACKGUM, CHEWING13
82442-029-02up and up uncoated nicotine310 in 1 CARTONGUM, CHEWING3103
82442-029-96up and up uncoated nicotine1 in 1 BLISTER PACKGUM, CHEWING13
82442-029-96up and up uncoated nicotine170 in 1 CARTONGUM, CHEWING1703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82442-029UP AND UP UNCOATED NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]2Current NDC, 4 package rows20240517_b7f79a60-4022-4bbe-ac13-67ec4de9f753.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNb7f79a60-4022-4bbe-ac13-67ec4de9f7533
314119nicotine 2 MG Chewing GumSCDb7f79a60-4022-4bbe-ac13-67ec4de9f7533
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYb7f79a60-4022-4bbe-ac13-67ec4de9f7533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82442-029-0282442002902310 BLISTER PACK in 1 CARTON (82442-029-02) / 1 GUM, CHEWING in 1 BLISTER PACK310 blister pack2024-05-14NoNoCurrent
82442-029-9682442002996170 BLISTER PACK in 1 CARTON (82442-029-96) / 1 GUM, CHEWING in 1 BLISTER PACK170 blister pack2024-05-14NoNoCurrent