FDA.reportPublic FDA data

Maxi Nicotine

Product NDC
0536-1338
11-digit product format
005361338
Labeler code
0536
Product ID
0536-1338_21f25fb4-08b3-4f4f-ad3f-3b8e0c6836f2
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Rugby Laboratories, Inc.
Application
ANDA209206
Marketing category
ANDA
Marketing start
2021-09-17
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1338-09Maxi Nicotine3 in 1 BOXLOZENGE36
0536-1338-09Maxi Nicotine24 in 1 BOTTLE, PLASTICLOZENGE246
0536-1338-35Maxi Nicotine24 in 1 BOTTLE, PLASTICLOZENGE246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1338-09EA - Each0536-13382f593a30-83f0-4a80-b412-4c2c5a8d09aa12021-12-08
0536-1338-35EA - Each0536-133813e0900c-52d2-48de-8ef7-b6aa839d509f12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1338MAXI NICOTINE (NICOTINE POLACRILEX) LOZENGE [RUGBY LABORATORIES, INC.]4Current NDC, Legacy NDC, 3 package rows20250112_7c2e0872-75f6-4c4f-afff-3579375708de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN7c2e0872-75f6-4c4f-afff-3579375708de6
359818nicotine 4 MG Oral LozengeSCD7c2e0872-75f6-4c4f-afff-3579375708de6
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY7c2e0872-75f6-4c4f-afff-3579375708de6
359818nicotine 4 MG TrocheSY7c2e0872-75f6-4c4f-afff-3579375708de6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1338-09005361338093 BOTTLE, PLASTIC in 1 BOX (0536-1338-09) / 24 LOZENGE in 1 BOTTLE, PLASTIC2021-09-170000-00-00NoNoCurrent
0536-1338-350053613383524 LOZENGE in 1 BOTTLE, PLASTIC (0536-1338-35) 24 lozenge2021-09-17NoNoCurrent