Equate Nicotine

Product NDC
49035-201
11-digit product format
490350201
Labeler code
49035
Product ID
49035-201_542314e5-6b18-4fb8-b661-2bb2f1f2c499
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA090821
Marketing category
ANDA
Marketing start
2016-10-11
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
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
49035-201-09Equate Nicotine27 in 1 CONTAINERLOZENGE274
49035-201-10Equate Nicotine27 in 1 CONTAINERLOZENGE274
49035-201-10Equate Nicotine4 in 1 CARTONLOZENGE44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-201-10EA - Each49035-20194c59a69-86e4-4769-8354-d03053ddb5b712017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-201EQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]4Current NDC, Legacy NDC, 3 package rows20230731_265e7411-45cd-4bd2-98fc-0401dfa52434.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN265e7411-45cd-4bd2-98fc-0401dfa524344
359817nicotine 2 MG Oral LozengeSCD265e7411-45cd-4bd2-98fc-0401dfa524344
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY265e7411-45cd-4bd2-98fc-0401dfa524344
359817nicotine 2 MG TrocheSY265e7411-45cd-4bd2-98fc-0401dfa524344

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-201-094903502010927 LOZENGE in 1 CONTAINER (49035-201-09) 27 lozenge2016-10-11NoNoHistorical
49035-201-10490350201104 CONTAINER in 1 CARTON (49035-201-10) / 27 LOZENGE in 1 CONTAINER4 container2016-10-110000-00-00NoNoCurrent