nicotine

Product NDC
30142-797
11-digit product format
301420797
Labeler code
30142
Product ID
30142-797_2adbdbe3-358c-4551-b15c-3aec1d1fb1f7
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Kroger Company
Application
ANDA203690
Marketing category
ANDA
Marketing start
2019-04-17
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
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
30142-797-07nicotine3 in 1 CARTONLOZENGE33
30142-797-09nicotine27 in 1 CONTAINERLOZENGE273

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-797NICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]2Current NDC, Legacy NDC, 2 package rows20190423_0b1874bd-f908-485a-b045-7d0050be7bb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN0b1874bd-f908-485a-b045-7d0050be7bb23
359818nicotine 4 MG Oral LozengeSCD0b1874bd-f908-485a-b045-7d0050be7bb23
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY0b1874bd-f908-485a-b045-7d0050be7bb23
359818nicotine 4 MG TrocheSY0b1874bd-f908-485a-b045-7d0050be7bb23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-797-07301420797073 CONTAINER in 1 CARTON (30142-797-07) / 27 LOZENGE in 1 CONTAINER (30142-797-09) 3 container2019-04-170000-00-00NoNoCurrent
30142-797-093014207970927 in 1 CONTAINERHistorical