QUITINE MINI NICOTINE

Product NDC
84720-034
11-digit product format
847200034
Labeler code
84720
Product ID
84720-034_f9d958e9-17aa-4714-b091-af5b3c9bdb1c
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
QUITINE LLC
Application
ANDA203690
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 MINI 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
84720-034-00QUITINE MINI NICOTINE27 in 1 CONTAINERLOZENGE272
84720-034-07QUITINE MINI NICOTINE8 in 1 CARTONLOZENGE82

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNd856379c-6334-4069-8382-ded2f86cf8a42
359817nicotine 2 MG Oral LozengeSCDd856379c-6334-4069-8382-ded2f86cf8a42
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYd856379c-6334-4069-8382-ded2f86cf8a42
359817nicotine 2 MG TrocheSYd856379c-6334-4069-8382-ded2f86cf8a42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84720-034-008472000340027 in 1 CONTAINERHistorical
84720-034-07847200034078 CONTAINER in 1 CARTON (84720-034-07) / 27 LOZENGE in 1 CONTAINER (84720-034-00) 8 container2025-12-04NoNoCurrent