quitine nicotine

Product NDC
84720-000
11-digit product format
847200000
Labeler code
84720
Product ID
84720-000_a7e8138b-8884-4cc9-9827-2ecd07f11ffd
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
QUITINE LLC
Application
ANDA077007
Marketing category
ANDA
Marketing start
2024-12-05
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
quitine 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
84720-000-58quitine nicotine40 in 1 VIALLOZENGE402
84720-000-76quitine nicotine3 in 1 CARTONLOZENGE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84720-000QUITINE NICOTINE (NICOTINE POLACRILEX) LOZENGE [QUITINE LLC]2Current NDC, 2 package rows20241215_fd9ce0e2-b159-4e0d-a76e-7223d36810fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNfd9ce0e2-b159-4e0d-a76e-7223d36810fb2
359817nicotine 2 MG Oral LozengeSCDfd9ce0e2-b159-4e0d-a76e-7223d36810fb2
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYfd9ce0e2-b159-4e0d-a76e-7223d36810fb2
359817nicotine 2 MG TrocheSYfd9ce0e2-b159-4e0d-a76e-7223d36810fb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84720-000-588472000005840 in 1 VIALHistorical
84720-000-76847200000763 VIAL in 1 CARTON (84720-000-76) / 40 LOZENGE in 1 VIAL (84720-000-58) 3 vial2024-12-05NoNoCurrent