exchange select nicotine

Product NDC
55301-734
11-digit product format
553010734
Labeler code
55301
Product ID
55301-734_2763a212-d5df-40a0-b50f-5870b9954a0d
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Army & Air Force Exchange Service
Application
ANDA203690
Marketing category
ANDA
Marketing start
2018-08-14
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
exchange select nicotine
Listing expiration
2027-12-31

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
55301-734-60exchange select nicotine20 in 1 VIALLOZENGE202
55301-734-60exchange select nicotine1 in 1 CARTONLOZENGE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-734EXCHANGE SELECT NICOTINE (NICOTINE POLACRILEX) LOZENGE [ARMY & AIR FORCE EXCHANGE SERVICE]1Current NDC, Legacy NDC, 2 package rows20180824_e39e82a5-f642-4643-8509-4e585b8fa566.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNe39e82a5-f642-4643-8509-4e585b8fa5662
359817nicotine 2 MG Oral LozengeSCDe39e82a5-f642-4643-8509-4e585b8fa5662
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYe39e82a5-f642-4643-8509-4e585b8fa5662
359817nicotine 2 MG TrocheSYe39e82a5-f642-4643-8509-4e585b8fa5662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-734-60553010734601 VIAL in 1 CARTON (55301-734-60) / 20 LOZENGE in 1 VIAL1 vial2018-08-140000-00-00NoNoCurrent