FDA.reportPublic FDA data

Equate Nicotine

Product NDC
49035-702
11-digit product format
490350702
Labeler code
49035
Product ID
49035-702_8038fc3a-3ff9-4ab6-8717-1abfae0518a5
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
2016-10-07
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
49035-702-09Equate Nicotine27 in 1 CONTAINERLOZENGE274
49035-702-10Equate Nicotine4 in 1 CARTONLOZENGE44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-702-10EA - Each49035-702d9b5a11b-4f7f-41c5-aeeb-a576565be5b912018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-702EQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC]4Current NDC, Legacy NDC, 2 package rows20230731_43a24aa7-ba1c-4c5d-9ec8-ed496e299e00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN43a24aa7-ba1c-4c5d-9ec8-ed496e299e004
359818nicotine 4 MG Oral LozengeSCD43a24aa7-ba1c-4c5d-9ec8-ed496e299e004
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY43a24aa7-ba1c-4c5d-9ec8-ed496e299e004
359818nicotine 4 MG TrocheSY43a24aa7-ba1c-4c5d-9ec8-ed496e299e004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-702-094903507020927 in 1 CONTAINERHistorical
49035-702-10490350702104 CONTAINER in 1 CARTON (49035-702-10) / 27 LOZENGE in 1 CONTAINER (49035-702-09) 4 container2016-10-070000-00-00NoNoCurrent