quitine nicotine

Product NDC
84720-007
11-digit product format
847200007
Labeler code
84720
Product ID
84720-007_90548f46-172c-45d9-81a4-fd06be02c2cc
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
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84720-007-58quitine nicotine40 in 1 VIALLOZENGE402
84720-007-76quitine nicotine3 in 1 CARTONLOZENGE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84720-007QUITINE NICOTINE (NICOTINE POLACRILEX) LOZENGE [QUITINE LLC]2Current NDC, 2 package rows20241215_21014e98-2c7c-4cc6-8595-a717910710a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN21014e98-2c7c-4cc6-8595-a717910710a42
359818nicotine 4 MG Oral LozengeSCD21014e98-2c7c-4cc6-8595-a717910710a42
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY21014e98-2c7c-4cc6-8595-a717910710a42
359818nicotine 4 MG TrocheSY21014e98-2c7c-4cc6-8595-a717910710a42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84720-007-588472000075840 in 1 VIALHistorical
84720-007-76847200007763 VIAL in 1 CARTON (84720-007-76) / 40 LOZENGE in 1 VIAL (84720-007-58) 3 vial2024-12-05NoNoCurrent