exchange select nicotine

Product NDC
55301-873
11-digit product format
553010873
Labeler code
55301
Product ID
55301-873_268ded35-3e84-43f7-b3ff-6fafc6c39aed
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Army & Air Force Exchange Service
Application
ANDA077007
Marketing category
ANDA
Marketing start
2018-09-19
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
exchange select 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
55301-873-16exchange select nicotine6 in 1 CARTONLOZENGE62
55301-873-16exchange select nicotine24 in 1 CONTAINERLOZENGE242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-873EXCHANGE SELECT NICOTINE (NICOTINE POLACRILEX) LOZENGE [ARMY & AIR FORCE EXCHANGE SERVICE]2Current NDC, Legacy NDC, 2 package rows20210605_0294974c-8d07-4a2e-b929-648c712b6ebe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN0294974c-8d07-4a2e-b929-648c712b6ebe2
359818nicotine 4 MG Oral LozengeSCD0294974c-8d07-4a2e-b929-648c712b6ebe2
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY0294974c-8d07-4a2e-b929-648c712b6ebe2
359818nicotine 4 MG TrocheSY0294974c-8d07-4a2e-b929-648c712b6ebe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-873-16553010873166 CONTAINER in 1 CARTON (55301-873-16) / 24 LOZENGE in 1 CONTAINER6 container2018-09-190000-00-00NoNoCurrent