Quitine nicotine

Product NDC
84720-124
11-digit product format
847200124
Labeler code
84720
Product ID
84720-124_bb6f505e-7311-4b3a-ada9-c3f57ee059e8
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
QUITINE LLC
Application
ANDA090711
Marketing category
ANDA
Marketing start
2025-12-04
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
84720-124-00Quitine nicotine24 in 1 CONTAINERLOZENGE242
84720-124-11Quitine nicotine7 in 1 CARTONLOZENGE72

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN90232b4e-cbf4-4d03-973a-41f4ebb4e5de2
359817nicotine 2 MG Oral LozengeSCD90232b4e-cbf4-4d03-973a-41f4ebb4e5de2
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY90232b4e-cbf4-4d03-973a-41f4ebb4e5de2
359817nicotine 2 MG TrocheSY90232b4e-cbf4-4d03-973a-41f4ebb4e5de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84720-124-008472001240024 in 1 CONTAINERHistorical
84720-124-11847200124117 CONTAINER in 1 CARTON (84720-124-11) / 24 LOZENGE in 1 CONTAINER (84720-124-00) 7 container2025-12-04NoNoCurrent