Nicotine Polacrilex

Product NDC
69842-428
11-digit product format
698420428
Labeler code
69842
Product ID
69842-428_e42098ad-5498-4210-9046-0c1987640246
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
CVS Pharmacy
Application
ANDA078699
Marketing category
ANDA
Marketing start
2014-01-01
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
Nicotine Polacrilex
Brand name suffix
coated mint
Listing expiration
2027-12-31

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
69842-428-16Nicotine Polacrilexcoated mint160 in 1 CARTONGUM, CHEWING16020
69842-428-16Nicotine Polacrilexcoated mint1 in 1 BLISTER PACKGUM, CHEWING120
69842-428-22Nicotine Polacrilexcoated mint1 in 1 BLISTER PACKGUM, CHEWING120
69842-428-22Nicotine Polacrilexcoated mint120 in 1 CARTONGUM, CHEWING12020
69842-428-79Nicotine Polacrilexcoated mint1 in 1 BLISTER PACKGUM, CHEWING120
69842-428-79Nicotine Polacrilexcoated mint10 in 1 CARTONGUM, CHEWING1020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-428NICOTINE POLACRILEX COATED MINT (NICOTINE POLACRILEX) GUM, CHEWING [CVS PHARMACY]10Current NDC, Legacy NDC, 6 package rows20241006_84daeb67-5982-4b9e-b56a-4cc6a223a3f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN84daeb67-5982-4b9e-b56a-4cc6a223a3f820
311975nicotine polacrilex 4 MG Chewing GumPSN84daeb67-5982-4b9e-b56a-4cc6a223a3f820
314119nicotine 2 MG Chewing GumSCD84daeb67-5982-4b9e-b56a-4cc6a223a3f820
311975nicotine 4 MG Chewing GumSCD84daeb67-5982-4b9e-b56a-4cc6a223a3f820
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY84daeb67-5982-4b9e-b56a-4cc6a223a3f820
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY84daeb67-5982-4b9e-b56a-4cc6a223a3f820

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-428-1669842042816160 BLISTER PACK in 1 CARTON (69842-428-16) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2014-01-010000-00-00NoNoCurrent
69842-428-2269842042822120 BLISTER PACK in 1 CARTON (69842-428-22) / 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2014-01-010000-00-00NoNoCurrent
69842-428-796984204287910 BLISTER PACK in 1 CARTON (69842-428-79) / 1 GUM, CHEWING in 1 BLISTER PACK10 blister pack2014-01-010000-00-00NoNoCurrent