FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
69842-025
11-digit product format
698420025
Labeler code
69842
Product ID
69842-025_100ca279-eb96-4ad3-b1f4-ff7037b7306d
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
CVS Pharmacy
Application
ANDA079038
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
2027-04-01
Substance
NICOTINE
Active strength
4 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 fruit

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 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
69842-025-15Nicotine Polacrilexcoated fruit1 in 1 BLISTER PACKGUM, CHEWING119
69842-025-15Nicotine Polacrilexcoated fruit20 in 1 CARTONGUM, CHEWING2019
69842-025-16Nicotine Polacrilexcoated fruit1 in 1 BLISTER PACKGUM, CHEWING119
69842-025-16Nicotine Polacrilexcoated fruit160 in 1 CARTONGUM, CHEWING16019
69842-025-44Nicotine Polacrilexcoated fruit1 in 1 BLISTER PACKGUM, CHEWING119
69842-025-44Nicotine Polacrilexcoated fruit100 in 1 CARTONGUM, CHEWING10019
69842-025-79Nicotine Polacrilexcoated fruit10 in 1 CARTONGUM, CHEWING1019
69842-025-79Nicotine Polacrilexcoated fruit1 in 1 BLISTER PACKGUM, CHEWING119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-025-15EA - Each69842-025dca4a11e-b000-40d9-bbae-d975c2aafc2512023-04-07
69842-025-44EA - Each69842-0252a487851-45b7-40b1-937d-afe1294b640b12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-025NICOTINE POLACRILEX COATED FRUIT (NICOTINE POLACRILEX) GUM, CHEWING [CVS PHARMACY]14Current NDC, Legacy NDC, 8 package rows20241016_8c5e99d7-9d2d-488b-a804-496edafd30cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN8c5e99d7-9d2d-488b-a804-496edafd30cf19
311975nicotine polacrilex 4 MG Chewing GumPSN8c5e99d7-9d2d-488b-a804-496edafd30cf19
314119nicotine 2 MG Chewing GumSCD8c5e99d7-9d2d-488b-a804-496edafd30cf19
311975nicotine 4 MG Chewing GumSCD8c5e99d7-9d2d-488b-a804-496edafd30cf19
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY8c5e99d7-9d2d-488b-a804-496edafd30cf19
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY8c5e99d7-9d2d-488b-a804-496edafd30cf19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-025-156984200251520 BLISTER PACK in 1 CARTON (69842-025-15) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2014-01-012027-04-01NoNoCurrent
69842-025-1669842002516160 BLISTER PACK in 1 CARTON (69842-025-16) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2014-01-012027-04-01NoNoCurrent
69842-025-4469842002544100 BLISTER PACK in 1 CARTON (69842-025-44) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2014-01-012027-04-01NoNoCurrent
69842-025-796984200257910 BLISTER PACK in 1 CARTON (69842-025-79) / 1 GUM, CHEWING in 1 BLISTER PACK10 blister pack2014-01-012027-04-01NoNoCurrent