FDA.reportPublic FDA data

UP AND UP COATED FRUIT NICOTINE

Product NDC
82442-971
11-digit product format
824420971
Labeler code
82442
Product ID
82442-971_8b54de24-d1ba-4dcf-a51f-bbce60c2f503
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Target Corporation
Application
ANDA206393
Marketing category
ANDA
Marketing start
2025-01-23
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
UP AND UP COATED FRUIT 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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82442-971-06UP AND UP COATED FRUIT NICOTINE1 in 1 BLISTER PACKGUM, CHEWING13
82442-971-06UP AND UP COATED FRUIT NICOTINE160 in 1 CARTONGUM, CHEWING1603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82442-971UP AND UP COATED FRUIT NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]2Current NDC, 2 package rows20250126_1bf2ad9e-213e-4e1f-817a-8c4b7d0cd789.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN1bf2ad9e-213e-4e1f-817a-8c4b7d0cd7893
311975nicotine 4 MG Chewing GumSCD1bf2ad9e-213e-4e1f-817a-8c4b7d0cd7893
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY1bf2ad9e-213e-4e1f-817a-8c4b7d0cd7893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82442-971-0682442097106160 BLISTER PACK in 1 CARTON (82442-971-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2025-01-23NoNoHistorical