FDA.reportPublic FDA data

nicotine mini

Product NDC
0363-1130
11-digit product format
003631130
Labeler code
0363
Product ID
0363-1130_f5749ca4-be90-4f3d-af46-4416037a8b1e
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA203690
Marketing category
ANDA
Marketing start
2018-11-20
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
nicotine mini
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
0363-1130-07nicotine mini3 in 1 CARTONLOZENGE35
0363-1130-09nicotine mini27 in 1 CONTAINERLOZENGE275
0363-1130-10nicotine mini4 in 1 CARTONLOZENGE45
0363-1130-60nicotine mini20 in 1 CONTAINERLOZENGE205
0363-1130-60nicotine mini1 in 1 CARTONLOZENGE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-1130-10EA - Each0363-11303f0807f7-1e01-4a81-85d4-33839820072c12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1130NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [WALGREEN COMPANY]4Current NDC, Legacy NDC, 5 package rows20230602_33e456bb-1d5d-4b06-8f06-8bb4eab5b1fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN33e456bb-1d5d-4b06-8f06-8bb4eab5b1fd5
359818nicotine 4 MG Oral LozengeSCD33e456bb-1d5d-4b06-8f06-8bb4eab5b1fd5
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY33e456bb-1d5d-4b06-8f06-8bb4eab5b1fd5
359818nicotine 4 MG TrocheSY33e456bb-1d5d-4b06-8f06-8bb4eab5b1fd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1130-07003631130073 CONTAINER in 1 CARTON (0363-1130-07) / 27 LOZENGE in 1 CONTAINER (0363-1130-09) 3 container2018-11-200000-00-00NoNoCurrent
0363-1130-090036311300927 in 1 CONTAINERHistorical
0363-1130-10003631130104 CONTAINER in 1 CARTON (0363-1130-10) > 27 LOZENGE in 1 CONTAINER4 container2019-04-120000-00-00NoNoCurrent
0363-1130-60003631130601 CONTAINER in 1 CARTON (0363-1130-60) / 20 LOZENGE in 1 CONTAINER1 container2018-11-200000-00-00NoNoCurrent