FDA.reportPublic FDA data

Equate nicotine

Product NDC
49035-029
11-digit product format
490350029
Labeler code
49035
Product ID
49035-029_ba31e5aa-69ca-4791-b903-4c7da046a809
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA076775
Marketing category
ANDA
Marketing start
2005-03-09
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-029-29Equate nicotine1 in 1 BLISTER PACKGUM, CHEWING19
49035-029-29Equate nicotine220 in 1 CARTONGUM, CHEWING2209
49035-029-96Equate nicotine1 in 1 BLISTER PACKGUM, CHEWING19
49035-029-96Equate nicotine170 in 1 CARTONGUM, CHEWING1709

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-029-96EA - Each49035-0295763da1b-c733-44fc-80de-4a94595e98f112013-06-04

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
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
POLACRILININACTIVE INGREDIENTRCZ785HI7SEQUATE 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
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-029EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]8Current NDC, Legacy NDC, 4 package rows20250521_da1ba4bc-6171-4cb8-a3e7-4972653ee269.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNda1ba4bc-6171-4cb8-a3e7-4972653ee2699
314119nicotine 2 MG Chewing GumSCDda1ba4bc-6171-4cb8-a3e7-4972653ee2699
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYda1ba4bc-6171-4cb8-a3e7-4972653ee2699

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-029-2949035002929220 BLISTER PACK in 1 CARTON (49035-029-29) / 1 GUM, CHEWING in 1 BLISTER PACK220 blister pack2020-04-230000-00-00NoNoCurrent
49035-029-9649035002996170 BLISTER PACK in 1 CARTON (49035-029-96) > 1 GUM, CHEWING in 1 BLISTER PACK170 blister pack2005-03-170000-00-00NoNoCurrent