QUITINE NICOTINE

Product NDC
84720-190
11-digit product format
847200190
Labeler code
84720
Product ID
84720-190_08f257a6-7361-4d10-b3d2-59dec1a69281
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
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
QUITINE 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
84720-190-00QUITINE NICOTINE24 in 1 CONTAINERLOZENGE245
84720-190-11QUITINE NICOTINE7 in 1 CARTONLOZENGE75

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN5d23992f-a010-4604-b64c-94ab6b134e6d5
359818nicotine 4 MG Oral LozengeSCD5d23992f-a010-4604-b64c-94ab6b134e6d5
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY5d23992f-a010-4604-b64c-94ab6b134e6d5
359818nicotine 4 MG TrocheSY5d23992f-a010-4604-b64c-94ab6b134e6d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84720-190-008472001900024 in 1 CONTAINERHistorical
84720-190-11847200190117 CONTAINER in 1 CARTON (84720-190-11) / 24 LOZENGE in 1 CONTAINER (84720-190-00) 7 container2025-12-04NoNoCurrent