equate nicotine

Product NDC
49035-124
11-digit product format
490350124
Labeler code
49035
Product ID
49035-124_853e0097-c2c8-4869-8a20-980b1b7f449d
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
2 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
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-124-09equate nicotine27 in 1 CONTAINERLOZENGE278
49035-124-10equate nicotine27 in 1 CONTAINERLOZENGE278
49035-124-10equate nicotine4 in 1 CARTONLOZENGE48

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-124-10EA - Each49035-124df40ff5d-fd46-47b6-bcd9-31d3b5c6ad1f12015-03-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-124EQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]8Current NDC, Legacy NDC, 3 package rows20230804_d0e94dfb-017a-4faf-8423-3417d517f39c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNd0e94dfb-017a-4faf-8423-3417d517f39c8
359817nicotine 2 MG Oral LozengeSCDd0e94dfb-017a-4faf-8423-3417d517f39c8
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYd0e94dfb-017a-4faf-8423-3417d517f39c8
359817nicotine 2 MG TrocheSYd0e94dfb-017a-4faf-8423-3417d517f39c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-124-094903501240927 LOZENGE in 1 CONTAINER (49035-124-09) 27 lozenge2009-09-10NoNoHistorical
49035-124-10490350124104 CONTAINER in 1 CARTON (49035-124-10) / 27 LOZENGE in 1 CONTAINER4 container2009-09-100000-00-00NoNoCurrent