FDA.reportPublic FDA data

Nicotine Polacrilex, Original

Product NDC
68016-287
11-digit product format
680160287
Labeler code
68016
Product ID
68016-287_b3555bc9-16a9-4ba6-a2cb-5c40ac2129c4
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA074707
Marketing category
ANDA
Marketing start
2013-06-01
Marketing end
2026-12-31
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, Original

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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-287-62Nicotine Polacrilex, Original11 in 1 CARTONGUM, CHEWING1115
68016-287-62Nicotine Polacrilex, Original10 in 1 BLISTER PACKGUM, CHEWING1015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-287NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]11Current NDC, Legacy NDC, 2 package rows20221122_cb67cd5e-9264-4530-a678-da299476f356.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNcb67cd5e-9264-4530-a678-da299476f35615
311975nicotine polacrilex 4 MG Chewing GumPSNcb67cd5e-9264-4530-a678-da299476f35615
314119nicotine 2 MG Chewing GumSCDcb67cd5e-9264-4530-a678-da299476f35615
311975nicotine 4 MG Chewing GumSCDcb67cd5e-9264-4530-a678-da299476f35615
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYcb67cd5e-9264-4530-a678-da299476f35615
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYcb67cd5e-9264-4530-a678-da299476f35615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-287-626801602876211 BLISTER PACK in 1 CARTON (68016-287-62) / 10 GUM, CHEWING in 1 BLISTER PACK11 blister pack2013-06-012026-12-31NoNoCurrent