FDA.reportPublic FDA data

Nicotine

Product NDC
0363-9580
11-digit product format
003639580
Labeler code
0363
Product ID
0363-9580_9e0dc481-384d-4c7b-a752-c0e75c3bc4f5
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreens
Application
ANDA209206
Marketing category
ANDA
Marketing start
2021-05-28
Marketing end
2027-05-28
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
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
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
0363-9580-08Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277
0363-9580-08Nicotine4 in 1 BOXLOZENGE47
0363-9580-24Nicotine24 in 1 BOTTLE, PLASTICLOZENGE247
0363-9580-24Nicotine1 in 1 BOXLOZENGE17
0363-9580-27Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277
0363-9580-27Nicotine1 in 1 BOXLOZENGE17
0363-9580-44Nicotine24 in 1 BOTTLE, PLASTICLOZENGE247
0363-9580-44Nicotine6 in 1 BOXLOZENGE67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9580NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS]5Current NDC, Legacy NDC, 8 package rows20221005_49a8e4f0-2b4c-4928-98f8-c8f9bb17c0f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN49a8e4f0-2b4c-4928-98f8-c8f9bb17c0f47
359818nicotine 4 MG Oral LozengeSCD49a8e4f0-2b4c-4928-98f8-c8f9bb17c0f47
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY49a8e4f0-2b4c-4928-98f8-c8f9bb17c0f47
359818nicotine 4 MG TrocheSY49a8e4f0-2b4c-4928-98f8-c8f9bb17c0f47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9580-08003639580084 BOTTLE, PLASTIC in 1 BOX (0363-9580-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC2021-05-282027-05-28NoNoCurrent
0363-9580-24003639580241 BOTTLE, PLASTIC in 1 BOX (0363-9580-24) / 24 LOZENGE in 1 BOTTLE, PLASTIC2021-05-282027-05-28NoNoCurrent
0363-9580-27003639580271 BOTTLE, PLASTIC in 1 BOX (0363-9580-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC2021-05-282027-05-28NoNoCurrent
0363-9580-44003639580446 BOTTLE, PLASTIC in 1 BOX (0363-9580-44) / 24 LOZENGE in 1 BOTTLE, PLASTIC2021-05-282027-05-28NoNoCurrent
0363-9580-72003639580723 BOTTLE, PLASTIC in 1 BOX (0363-9580-72) > 24 LOZENGE in 1 BOTTLE, PLASTIC2021-05-280000-00-00NoNoCurrent