FDA.reportPublic FDA data

Equate Nicotine

Product NDC
49035-456
11-digit product format
490350456
Labeler code
49035
Product ID
49035-456_b3b2b719-aabe-4ae3-8e24-8f201942dbde
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA076777
Marketing category
ANDA
Marketing start
2007-05-09
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
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
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
49035-456-06Equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
49035-456-06Equate Nicotine160 in 1 CARTONGUM, CHEWING16012
49035-456-20Equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
49035-456-20Equate Nicotine200 in 1 CARTONGUM, CHEWING20012
49035-456-52Equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
49035-456-52Equate Nicotine10 in 1 CARTONGUM, CHEWING1012
49035-456-60Equate Nicotine20 in 1 CARTONGUM, CHEWING2012
49035-456-60Equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
49035-456-76Equate Nicotine120 in 1 CARTONGUM, CHEWING12012
49035-456-76Equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
49035-456-78Equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
49035-456-78Equate Nicotine100 in 1 CARTONGUM, CHEWING10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-456-06EA - Each49035-456fa575b11-8bcd-4e3d-b09c-d3813d973ef312018-10-11
49035-456-60EA - Each49035-456131ca9ab-a1b6-45ed-9e00-bf5b81ccd5c412013-07-02
49035-456-78EA - Each49035-45644b51a46-6a42-4c5d-9912-f3bb24a8048b12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
NICOTINEACTIVE MOIETY6M3C89ZY6REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
GELATININACTIVE INGREDIENT2G86QN327LEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
POLACRILININACTIVE INGREDIENTRCZ785HI7SEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
SORBITOLINACTIVE INGREDIENT506T60A25REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-456EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]10Current NDC, Legacy NDC, 12 package rows20240817_519788c4-10fc-4395-9114-74e996e103fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN519788c4-10fc-4395-9114-74e996e103fa12
314119nicotine 2 MG Chewing GumSCD519788c4-10fc-4395-9114-74e996e103fa12
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY519788c4-10fc-4395-9114-74e996e103fa12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-456-0649035045606160 BLISTER PACK in 1 CARTON (49035-456-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2008-10-110000-00-00NoNoCurrent
49035-456-2049035045620200 BLISTER PACK in 1 CARTON (49035-456-20) / 1 GUM, CHEWING in 1 BLISTER PACK200 blister pack2025-08-22NoNoCurrent
49035-456-52490350456521 in 1 BLISTER PACKHistorical
49035-456-604903504566020 BLISTER PACK in 1 CARTON (49035-456-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2009-04-150000-00-00NoNoCurrent
49035-456-7649035045676120 in 1 CARTONHistorical
49035-456-7849035045678100 BLISTER PACK in 1 CARTON (49035-456-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2007-05-090000-00-00NoNoCurrent