Good Sense Nicotine

Product NDC
0113-1125
11-digit product format
001131125
Labeler code
0113
Product ID
0113-1125_dbad958f-af3a-44c2-ab45-52f562df41a7
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA090711
Marketing category
ANDA
Marketing start
2020-07-07
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
Good Sense 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
0113-1125-05Good Sense Nicotine3 in 1 CARTONLOZENGE33
0113-1125-09Good Sense Nicotine27 in 1 CONTAINERLOZENGE273
0113-1125-10Good Sense Nicotine4 in 1 CARTONLOZENGE43
0113-1125-24Good Sense Nicotine24 in 1 CONTAINERLOZENGE243

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-1125-10EA - Each0113-112572683235-99a1-4f19-b3ef-0d7f97944ba612024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1125GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]1Current NDC, Legacy NDC, 4 package rows20200723_dd334b2c-bbae-48e7-8f3d-2706d325f600.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNdd334b2c-bbae-48e7-8f3d-2706d325f6003
359817nicotine 2 MG Oral LozengeSCDdd334b2c-bbae-48e7-8f3d-2706d325f6003
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYdd334b2c-bbae-48e7-8f3d-2706d325f6003
359817nicotine 2 MG TrocheSYdd334b2c-bbae-48e7-8f3d-2706d325f6003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-1125-05001131125053 in 1 CARTONHistorical
0113-1125-090011311250927 in 1 CONTAINERHistorical
0113-1125-10001131125104 CONTAINER in 1 CARTON (0113-1125-10) / 27 LOZENGE in 1 CONTAINER (0113-1125-09) 4 container2020-07-070000-00-00NoNoCurrent
0113-1125-240011311252424 in 1 CONTAINERHistorical