Topcare Nicotine Polacrilex

Product NDC
36800-344
11-digit product format
368000344
Labeler code
36800
Product ID
36800-344_2491860b-a095-4eb9-abc1-ec4619c2c5e3
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA077007
Marketing category
ANDA
Marketing start
2009-09-03
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
36800-344-03Topcare Nicotine Polacrilex24 in 1 CONTAINERLOZENGE247
36800-344-05Topcare Nicotine Polacrilex3 in 1 CARTONLOZENGE37
36800-344-06Topcare Nicotine Polacrilex24 in 1 CONTAINERLOZENGE247
36800-344-06Topcare Nicotine Polacrilex4 in 1 CARTONLOZENGE47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-344-03EA - Each36800-34433464911-e144-4b38-8a00-43df44bfdf5c12019-03-12
36800-344-05EA - Each36800-3440a206a95-6bf6-42e5-9c51-4fe40d98c14b12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-344TOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]7Legacy NDC, 4 package rows20231208_01e90106-4f97-4ae4-8d48-3e5adffd716b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN01e90106-4f97-4ae4-8d48-3e5adffd716b7
359817nicotine 2 MG Oral LozengeSCD01e90106-4f97-4ae4-8d48-3e5adffd716b7
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY01e90106-4f97-4ae4-8d48-3e5adffd716b7
359817nicotine 2 MG TrocheSY01e90106-4f97-4ae4-8d48-3e5adffd716b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-344-033680003440324 in 1 CONTAINERHistorical
36800-344-05368000344053 CONTAINER in 1 CARTON (36800-344-05) > 24 LOZENGE in 1 CONTAINER (36800-344-03) 3 container2009-09-030000-00-00NoNoCurrent
36800-344-06368000344064 CONTAINER in 1 CARTON (36800-344-06) > 24 LOZENGE in 1 CONTAINER4 container2011-09-150000-00-00NoNoCurrent