FDA.reportPublic FDA data

equate nicotine

Product NDC
49035-365
11-digit product format
490350365
Labeler code
49035
Product ID
49035-365_8e0bf5bf-7f70-4c2e-824c-c43d0e695867
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA091349
Marketing category
ANDA
Marketing start
2011-10-04
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
equate 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
49035-365-06equate nicotine160 in 1 CARTONGUM, CHEWING16010
49035-365-06equate nicotine1 in 1 BLISTER PACKGUM, CHEWING110
49035-365-20equate nicotine200 in 1 CARTONGUM, CHEWING20010
49035-365-20equate nicotine1 in 1 BLISTER PACKGUM, CHEWING110
49035-365-60equate nicotine20 in 1 CARTONGUM, CHEWING2010
49035-365-60equate nicotine1 in 1 BLISTER PACKGUM, CHEWING110
49035-365-76equate nicotine1 in 1 BLISTER PACKGUM, CHEWING110
49035-365-76equate nicotine120 in 1 CARTONGUM, CHEWING12010
49035-365-78equate nicotine100 in 1 CARTONGUM, CHEWING10010
49035-365-78equate nicotine1 in 1 BLISTER PACKGUM, CHEWING110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-365-78EA - Each49035-365767ca1cd-3694-410b-b4be-9613fcc210cc12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
NICOTINEACTIVE MOIETY6M3C89ZY6REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
ACACIAINACTIVE INGREDIENT5C5403N26OEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
MALTITOLINACTIVE INGREDIENTD65DG142WKEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
MENTHOLINACTIVE INGREDIENTL7T10EIP3AEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
POLACRILININACTIVE INGREDIENTRCZ785HI7SEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
SORBITOLINACTIVE INGREDIENT506T60A25REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-365EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]8Current NDC, Legacy NDC, 10 package rows20241017_83532228-931b-43ab-8a3d-0c2a74d4e010.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN83532228-931b-43ab-8a3d-0c2a74d4e01010
314119nicotine 2 MG Chewing GumSCD83532228-931b-43ab-8a3d-0c2a74d4e01010
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY83532228-931b-43ab-8a3d-0c2a74d4e01010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-365-0649035036506160 BLISTER PACK in 1 CARTON (49035-365-06) > 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2017-08-080000-00-00NoNoCurrent
49035-365-2049035036520200 BLISTER PACK in 1 CARTON (49035-365-20) / 1 GUM, CHEWING in 1 BLISTER PACK200 blister pack2025-08-22NoNoCurrent
49035-365-604903503656020 BLISTER PACK in 1 CARTON (49035-365-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2017-08-080000-00-00NoNoCurrent
49035-365-76490350365761 in 1 BLISTER PACKHistorical
49035-365-7849035036578100 BLISTER PACK in 1 CARTON (49035-365-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2011-10-040000-00-00NoNoCurrent