Nicotine

Product NDC
70000-0562
11-digit product format
700000562
Labeler code
70000
Product ID
70000-0562_896ae63a-74db-41ce-80e3-59b1b2734f93
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Cardinal Health (Leader) 70000
Application
ANDA209206
Marketing category
ANDA
Marketing start
2020-07-01
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
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
70000-0562-1Nicotine3 in 1 BOXLOZENGE34
70000-0562-1Nicotine24 in 1 BOTTLE, PLASTICLOZENGE244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0562-1EA - Each70000-0562647620ad-a4e1-497e-a45f-30699750ce8712021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0562NICOTINE (NICOTINE POLACRILEX) LOZENGE [CARDINAL HEALTH (LEADER) 70000]4Current NDC, Legacy NDC, 2 package rows20250228_80195d3b-9341-4354-8a65-b5b080b524d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN80195d3b-9341-4354-8a65-b5b080b524d04
359817nicotine 2 MG Oral LozengeSCD80195d3b-9341-4354-8a65-b5b080b524d04
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY80195d3b-9341-4354-8a65-b5b080b524d04
359817nicotine 2 MG TrocheSY80195d3b-9341-4354-8a65-b5b080b524d04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0562-1700000562013 BOTTLE, PLASTIC in 1 BOX (70000-0562-1) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-07-010000-00-00NoNoCurrent