NICOTINE

Product NDC
82966-002
11-digit product format
829660002
Labeler code
82966
Product ID
82966-002_cf7fbe21-9a76-4832-88a4-2ef371510784
Type
HUMAN OTC DRUG
Nonproprietary name
NICOTINE POLACRILEX MINI
Dosage form
LOZENGE
Route
ORAL
Labeler
BLIP PRODUCTS, INC.
Application
ANDA215357
Marketing category
ANDA
Marketing start
2023-01-06
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NICOTINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359818

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
82966-002-81NICOTINE4 in 1 CARTONLOZENGE43
82966-002-81NICOTINE27 in 1 CONTAINERLOZENGE273
82966-002-83NICOTINE27 in 1 CONTAINERLOZENGE273
82966-002-83NICOTINE1 in 1 CARTONLOZENGE13
82966-002-84NICOTINE27 in 1 CONTAINERLOZENGE273
82966-002-84NICOTINE3 in 1 CARTONLOZENGE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82966-002NICOTINE (NICOTINE POLACRILEX MINI) LOZENGE [BLIP PRODUCTS, INC.]3Current NDC, Legacy NDC, 6 package rows20230818_eb714022-332d-5c6f-e053-2a95a90a75c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNeb714022-332d-5c6f-e053-2a95a90a75c93
359818nicotine 4 MG Oral LozengeSCDeb714022-332d-5c6f-e053-2a95a90a75c93
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYeb714022-332d-5c6f-e053-2a95a90a75c93
359818nicotine 4 MG TrocheSYeb714022-332d-5c6f-e053-2a95a90a75c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82966-002-81829660002814 CONTAINER in 1 CARTON (82966-002-81) / 27 LOZENGE in 1 CONTAINER4 container2023-01-060000-00-00NoNoCurrent
82966-002-83829660002831 CONTAINER in 1 CARTON (82966-002-83) / 27 LOZENGE in 1 CONTAINER1 container2023-01-060000-00-00NoNoCurrent
82966-002-84829660002843 CONTAINER in 1 CARTON (82966-002-84) / 27 LOZENGE in 1 CONTAINER3 container2023-08-11NoNoCurrent