FDA.reportPublic FDA data

equate nicotine

Product NDC
79903-182
11-digit product format
799030182
Labeler code
79903
Product ID
79903-182_ad49b333-a8d2-4355-b2af-641b38ba8ddf
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
WALMART INC.
Application
ANDA077007
Marketing category
ANDA
Marketing start
2023-06-07
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
equate 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
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
79903-182-20equate nicotine20 in 1 CONTAINERLOZENGE202
79903-182-20equate nicotine1 in 1 CARTONLOZENGE12
79903-182-40equate nicotine40 in 1 CONTAINERLOZENGE402
79903-182-80equate nicotine2 in 1 CARTONLOZENGE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-182EQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALMART INC.]2Current NDC, 4 package rows20230619_0f625e1a-be08-4460-a588-8b42282ac121.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN0f625e1a-be08-4460-a588-8b42282ac1212
359818nicotine 4 MG Oral LozengeSCD0f625e1a-be08-4460-a588-8b42282ac1212
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY0f625e1a-be08-4460-a588-8b42282ac1212
359818nicotine 4 MG TrocheSY0f625e1a-be08-4460-a588-8b42282ac1212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-182-20799030182201 CONTAINER in 1 CARTON (79903-182-20) / 20 LOZENGE in 1 CONTAINER1 container2023-06-15NoNoCurrent
79903-182-407990301824040 in 1 CONTAINERHistorical
79903-182-80799030182802 CONTAINER in 1 CARTON (79903-182-80) / 40 LOZENGE in 1 CONTAINER (79903-182-40) 2 container2023-06-07NoNoCurrent