NICOTINE

Product NDC
82966-001
11-digit product format
829660001
Labeler code
82966
Product ID
82966-001_52194405-c68d-4597-bb3c-78e53eadda3a
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
2 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
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817

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
82966-001-81NICOTINE27 in 1 CONTAINERLOZENGE273
82966-001-81NICOTINE4 in 1 CARTONLOZENGE43
82966-001-83NICOTINE27 in 1 CONTAINERLOZENGE273
82966-001-83NICOTINE1 in 1 CARTONLOZENGE13
82966-001-84NICOTINE3 in 1 CARTONLOZENGE33
82966-001-84NICOTINE27 in 1 CONTAINERLOZENGE273

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82966-001NICOTINE (NICOTINE POLACRILEX MINI) LOZENGE [BLIP PRODUCTS, INC.]3Current NDC, Legacy NDC, 6 package rows20230818_e88c8815-4d38-3a59-e053-2995a90afc82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNe88c8815-4d38-3a59-e053-2995a90afc823
359817nicotine 2 MG Oral LozengeSCDe88c8815-4d38-3a59-e053-2995a90afc823
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYe88c8815-4d38-3a59-e053-2995a90afc823
359817nicotine 2 MG TrocheSYe88c8815-4d38-3a59-e053-2995a90afc823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82966-001-81829660001814 CONTAINER in 1 CARTON (82966-001-81) / 27 LOZENGE in 1 CONTAINER4 container2023-01-060000-00-00NoNoCurrent
82966-001-83829660001831 CONTAINER in 1 CARTON (82966-001-83) / 27 LOZENGE in 1 CONTAINER1 container2023-01-060000-00-00NoNoCurrent
82966-001-84829660001843 CONTAINER in 1 CARTON (82966-001-84) / 27 LOZENGE in 1 CONTAINER3 container2023-08-11NoNoCurrent