Nicotine Polacrilex

Product NDC
68071-2722
11-digit product format
680712722
Labeler code
68071
Product ID
68071-2722_dfaf8a04-7137-8327-e053-2a95a90ad0e1
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA212796
Marketing category
ANDA
Marketing start
2020-06-09
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2722-72025-01-30C16284748780-12cef2736-617e-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2722-7Nicotine Polacrilex72 in 1 CARTONLOZENGE721
68071-2722-7Nicotine Polacrilex24 in 1 BOTTLELOZENGE241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2722NICOTINE POLACRILEX LOZENGE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220524_dfaf8a76-c5a2-6920-e053-2995a90abc5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNdfaf8a76-c5a2-6920-e053-2995a90abc5a1
359818nicotine 4 MG Oral LozengeSCDdfaf8a76-c5a2-6920-e053-2995a90abc5a1
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYdfaf8a76-c5a2-6920-e053-2995a90abc5a1
359818nicotine 4 MG TrocheSYdfaf8a76-c5a2-6920-e053-2995a90abc5a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2722-76807127220772 BOTTLE in 1 CARTON (68071-2722-7) > 24 LOZENGE in 1 BOTTLE72 bottle2022-05-230000-00-00NoNoCurrent