Maxi Nicotine

Product NDC
70000-0561
11-digit product format
700000561
Labeler code
70000
Product ID
70000-0561_fc3c17b9-8f9f-4ff9-b24f-ff6df0ff4cec
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
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
Maxi 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
70000-0561-1Maxi Nicotine24 in 1 BOTTLE, PLASTICLOZENGE244
70000-0561-1Maxi Nicotine3 in 1 BOXLOZENGE34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0561-1EA - Each70000-056184071f96-2669-40f3-b012-becae5b3338512021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0561MAXI NICOTINE (NICOTINE POLACRILEX) LOZENGE [CARDINAL HEALTH (LEADER) 70000]4Current NDC, Legacy NDC, 2 package rows20250228_362b4a04-4a5f-4af6-9cd7-82aa172b7afb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN362b4a04-4a5f-4af6-9cd7-82aa172b7afb4
359818nicotine 4 MG Oral LozengeSCD362b4a04-4a5f-4af6-9cd7-82aa172b7afb4
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY362b4a04-4a5f-4af6-9cd7-82aa172b7afb4
359818nicotine 4 MG TrocheSY362b4a04-4a5f-4af6-9cd7-82aa172b7afb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0561-1700000561013 BOTTLE, PLASTIC in 1 BOX (70000-0561-1) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-07-010000-00-00NoNoCurrent