FDA.reportPublic FDA data

Equate Nicotine

Product NDC
49035-998
11-digit product format
490350998
Labeler code
49035
Product ID
49035-998_0cbc7c2c-06e2-4e3e-9d48-bcfb0fb602d3
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA077007
Marketing category
ANDA
Marketing start
2006-12-15
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
Equate 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-998-032025-02-04C16284748780-12cef2736-ad90-d83d-e063-dadaa90ab31fWal-Mart Nicotine Lozenges Drug Facts
49035-998-092025-02-04C16284748780-12cef2736-ad90-d83d-e063-dadaa90ab31fWal-Mart Nicotine Lozenges Drug Facts
49035-998-102025-02-04C16284748780-12cef2736-ad90-d83d-e063-dadaa90ab31fWal-Mart Nicotine Lozenges Drug Facts
49035-998-112025-02-04C16284748780-12cef2736-ad90-d83d-e063-dadaa90ab31fWal-Mart Nicotine Lozenges Drug Facts
49035-998-032025-01-30C16284748780-12cef2736-ad90-d83d-e063-dadaa90ab31fWal-Mart Nicotine Lozenges Drug Facts
49035-998-092025-01-30C16284748780-12cef2736-ad90-d83d-e063-dadaa90ab31fWal-Mart Nicotine Lozenges Drug Facts
49035-998-102025-01-30C16284748780-12cef2736-ad90-d83d-e063-dadaa90ab31fWal-Mart Nicotine Lozenges Drug Facts
49035-998-112025-01-30C16284748780-12cef2736-ad90-d83d-e063-dadaa90ab31fWal-Mart Nicotine Lozenges Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-998-03Equate Nicotine24 in 1 CONTAINERLOZENGE2411
49035-998-03Equate Nicotine1 in 1 CARTONLOZENGE111
49035-998-09Equate Nicotine27 in 1 CONTAINERLOZENGE2711
49035-998-10Equate Nicotine4 in 1 CARTONLOZENGE411
49035-998-11Equate Nicotine7 in 1 CARTONLOZENGE711
49035-998-11Equate Nicotine24 in 1 CONTAINERLOZENGE2411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-998-03EA - Each49035-99854958eae-f3ba-4234-8f3f-1a8b1219c39212024-09-09
49035-998-10EA - Each49035-998c30253d4-eba3-4e33-965b-2701fe0556cc12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6REQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]2
NICOTINEACTIVE MOIETY6M3C89ZY6REQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1EQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AEQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]2
POLACRILININACTIVE INGREDIENTRCZ785HI7SEQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]2
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNEQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQEQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TEQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEEQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-998EQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]10Current NDC, Legacy NDC, 6 package rows20250205_19fad004-2997-4169-939a-dc525dc9e6cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN19fad004-2997-4169-939a-dc525dc9e6cc11
359817nicotine 2 MG Oral LozengeSCD19fad004-2997-4169-939a-dc525dc9e6cc11
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY19fad004-2997-4169-939a-dc525dc9e6cc11
359817nicotine 2 MG TrocheSY19fad004-2997-4169-939a-dc525dc9e6cc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-998-03490350998031 CONTAINER in 1 CARTON (49035-998-03) / 24 LOZENGE in 1 CONTAINER1 container2011-10-070000-00-00NoNoCurrent
49035-998-094903509980927 in 1 CONTAINERHistorical
49035-998-10490350998104 CONTAINER in 1 CARTON (49035-998-10) / 27 LOZENGE in 1 CONTAINER (49035-998-09) 4 container2010-03-240000-00-00NoNoCurrent
49035-998-11490350998117 CONTAINER in 1 CARTON (49035-998-11) / 24 LOZENGE in 1 CONTAINER7 container2020-04-170000-00-00NoNoCurrent