exchange select nicotine

Product NDC
55301-957
11-digit product format
553010957
Labeler code
55301
Product ID
55301-957_e926cf6f-305a-4912-be07-a45bb7905822
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
2018-09-19
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-957-60exchange select nicotine20 in 1 CONTAINERLOZENGE201
55301-957-60exchange select nicotine1 in 1 CARTONLOZENGE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-957EXCHANGE SELECT NICOTINE (NICOTINE POLACRILEX) LOZENGE [ARMY & AIR FORCE EXCHANGE SERVICE]1Current NDC, Legacy NDC, 2 package rows20180925_e926cf6f-305a-4912-be07-a45bb7905822.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNe926cf6f-305a-4912-be07-a45bb79058221
359818nicotine 4 MG Oral LozengeSCDe926cf6f-305a-4912-be07-a45bb79058221
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYe926cf6f-305a-4912-be07-a45bb79058221
359818nicotine 4 MG TrocheSYe926cf6f-305a-4912-be07-a45bb79058221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-957-60553010957601 CONTAINER in 1 CARTON (55301-957-60) / 20 LOZENGE in 1 CONTAINER1 container2018-09-190000-00-00NoNoCurrent