FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
68016-280
11-digit product format
680160280
Labeler code
68016
Product ID
68016-280_4004f343-1acc-48c7-a332-f0fbf9aca9b2
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA078699
Marketing category
ANDA
Marketing start
2013-07-01
Marketing end
2027-01-28
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Polacrilex
Brand name suffix
Coated Mint

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975, 314119

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
68016-280-49Nicotine PolacrilexCoated Mint4 in 1 CARTONGUM, CHEWING433
68016-280-49Nicotine PolacrilexCoated Mint10 in 1 BLISTER PACKGUM, CHEWING1033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-280-49EA - Each68016-280afcd4708-c6b0-479f-8889-d6e947044e7012014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
ACACIAINACTIVE INGREDIENT5C5403N26ONICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PNICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GNICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QONICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UNICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ENICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-280NICOTINE POLACRILEX COATED MINT (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]25Current NDC, Legacy NDC, 2 package rows20221021_b4ac0a22-3556-4591-aa7b-e09c6010adc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNb4ac0a22-3556-4591-aa7b-e09c6010adc833
311975nicotine polacrilex 4 MG Chewing GumPSNb4ac0a22-3556-4591-aa7b-e09c6010adc833
314119nicotine 2 MG Chewing GumSCDb4ac0a22-3556-4591-aa7b-e09c6010adc833
311975nicotine 4 MG Chewing GumSCDb4ac0a22-3556-4591-aa7b-e09c6010adc833
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYb4ac0a22-3556-4591-aa7b-e09c6010adc833
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYb4ac0a22-3556-4591-aa7b-e09c6010adc833

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-280-49680160280494 BLISTER PACK in 1 CARTON (68016-280-49) / 10 GUM, CHEWING in 1 BLISTER PACK4 blister pack2013-07-012027-01-28NoNoCurrent