Equate Nicotine

Product NDC
49035-190
11-digit product format
490350190
Labeler code
49035
Product ID
49035-190_e56b903c-4989-447b-9613-ce4e46679641
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA090711
Marketing category
ANDA
Marketing start
2009-09-10
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
49035-190-09Equate Nicotine27 in 1 CONTAINERLOZENGE278
49035-190-10Equate Nicotine4 in 1 CARTONLOZENGE48
49035-190-10Equate Nicotine27 in 1 CONTAINERLOZENGE278

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-190-10EA - Each49035-190504f946c-c0ab-43f5-82d8-9973afa3f2c912013-05-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-190EQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]8Current NDC, Legacy NDC, 3 package rows20230805_0100787d-59f0-4f7f-ac13-92d1162cdc1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN0100787d-59f0-4f7f-ac13-92d1162cdc1b8
359818nicotine 4 MG Oral LozengeSCD0100787d-59f0-4f7f-ac13-92d1162cdc1b8
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY0100787d-59f0-4f7f-ac13-92d1162cdc1b8
359818nicotine 4 MG TrocheSY0100787d-59f0-4f7f-ac13-92d1162cdc1b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-190-094903501900927 LOZENGE in 1 CONTAINER (49035-190-09) 27 lozenge2009-09-10NoNoHistorical
49035-190-10490350190104 CONTAINER in 1 CARTON (49035-190-10) / 27 LOZENGE in 1 CONTAINER4 container2009-09-100000-00-00NoNoCurrent