FDA.reportPublic FDA data

Maxi Nicotine

Product NDC
0363-0960
11-digit product format
003630960
Labeler code
0363
Product ID
0363-0960_fc34920e-93d7-40e0-803c-ad0a5f8e4060
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreens
Application
ANDA210712
Marketing category
ANDA
Marketing start
2020-10-30
Marketing end
2027-04-30
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Maxi Nicotine

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
0363-0960-08Maxi Nicotine27 in 1 BOTTLE, PLASTICLOZENGE275
0363-0960-08Maxi Nicotine4 in 1 BOXLOZENGE45
0363-0960-24Maxi Nicotine1 in 1 BOXLOZENGE15
0363-0960-24Maxi Nicotine24 in 1 BOTTLE, PLASTICLOZENGE245
0363-0960-27Maxi Nicotine1 in 1 BOXLOZENGE15
0363-0960-27Maxi Nicotine27 in 1 BOTTLE, PLASTICLOZENGE275
0363-0960-72Maxi Nicotine24 in 1 BOTTLE, PLASTICLOZENGE245
0363-0960-72Maxi Nicotine3 in 1 BOXLOZENGE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0960MAXI NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS]4Current NDC, Legacy NDC, 8 package rows20221007_7a25d940-6aca-47fe-9c77-babef21a4c80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN7a25d940-6aca-47fe-9c77-babef21a4c805
359818nicotine 4 MG Oral LozengeSCD7a25d940-6aca-47fe-9c77-babef21a4c805
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY7a25d940-6aca-47fe-9c77-babef21a4c805
359818nicotine 4 MG TrocheSY7a25d940-6aca-47fe-9c77-babef21a4c805

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0960-08003630960084 BOTTLE, PLASTIC in 1 BOX (0363-0960-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-10-302027-04-30NoNoCurrent
0363-0960-24003630960241 BOTTLE, PLASTIC in 1 BOX (0363-0960-24) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-10-302027-04-30NoNoCurrent
0363-0960-27003630960271 BOTTLE, PLASTIC in 1 BOX (0363-0960-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-10-302027-04-30NoNoCurrent
0363-0960-72003630960723 BOTTLE, PLASTIC in 1 BOX (0363-0960-72) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-10-302027-04-30NoNoCurrent