nicotine

Product NDC
0363-7044
11-digit product format
003637044
Labeler code
0363
Product ID
0363-7044_73b569e0-71dd-4dd7-a48f-ab2d0af17834
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA077007
Marketing category
ANDA
Marketing start
2024-03-05
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
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
0363-7044-01nicotine40 in 1 CONTAINERLOZENGE403
0363-7044-02nicotine2 in 1 CARTONLOZENGE23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7044NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREEN COMPANY]2Current NDC, 2 package rows20240415_6c5d786b-8b5a-460a-ae67-c11de9858ad4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN6c5d786b-8b5a-460a-ae67-c11de9858ad43
359818nicotine 4 MG Oral LozengeSCD6c5d786b-8b5a-460a-ae67-c11de9858ad43
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY6c5d786b-8b5a-460a-ae67-c11de9858ad43
359818nicotine 4 MG TrocheSY6c5d786b-8b5a-460a-ae67-c11de9858ad43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-7044-010036370440140 in 1 CONTAINERHistorical
0363-7044-02003637044022 CONTAINER in 1 CARTON (0363-7044-02) / 40 LOZENGE in 1 CONTAINER (0363-7044-01) 2 container2024-03-05NoNoCurrent