Nicotine

Product NDC
0363-4190
11-digit product format
003634190
Labeler code
0363
Product ID
0363-4190_1cfddf2c-38d8-4d74-8d96-6f42efe7650d
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA090711
Marketing category
ANDA
Marketing start
2014-11-05
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Listing expiration
2027-12-31

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
0363-4190-03Nicotine24 in 1 CONTAINERLOZENGE246
0363-4190-05Nicotine3 in 1 CARTONLOZENGE36
0363-4190-06Nicotine24 in 1 CONTAINERLOZENGE246
0363-4190-06Nicotine4 in 1 CARTONLOZENGE46
0363-4190-09Nicotine27 in 1 CONTAINERLOZENGE276
0363-4190-10Nicotine4 in 1 CARTONLOZENGE46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-4190-05EA - Each0363-41902e5ea5f3-aeb1-49e9-bed1-c35da159c5b612022-06-06
0363-4190-06EA - Each0363-4190b625dac1-5a82-4ed8-97a0-c6a4a2b1bc3712022-06-06
0363-4190-10EA - Each0363-4190b088bbee-0073-4582-8cbd-276f51c528fc12020-05-08

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4190NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREEN COMPANY]5Current NDC, Legacy NDC, 6 package rows20230504_74f306d4-2a71-48c9-ab98-378260507a9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN74f306d4-2a71-48c9-ab98-378260507a9d6
359818nicotine 4 MG Oral LozengeSCD74f306d4-2a71-48c9-ab98-378260507a9d6
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY74f306d4-2a71-48c9-ab98-378260507a9d6
359818nicotine 4 MG TrocheSY74f306d4-2a71-48c9-ab98-378260507a9d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-4190-030036341900324 in 1 CONTAINERHistorical
0363-4190-05003634190053 CONTAINER in 1 CARTON (0363-4190-05) / 24 LOZENGE in 1 CONTAINER (0363-4190-03) 3 container2014-11-050000-00-00NoNoCurrent
0363-4190-06003634190064 CONTAINER in 1 CARTON (0363-4190-06) > 24 LOZENGE in 1 CONTAINER4 container2014-11-050000-00-00NoNoCurrent
0363-4190-090036341900927 in 1 CONTAINERHistorical
0363-4190-10003634190104 CONTAINER in 1 CARTON (0363-4190-10) / 27 LOZENGE in 1 CONTAINER (0363-4190-09) 4 container2014-11-050000-00-00NoNoCurrent