FDA.reportPublic FDA data

nicotine

Product NDC
0363-7971
11-digit product format
003637971
Labeler code
0363
Product ID
0363-7971_a0eb900c-b68c-4218-8f43-6eaed4e10493
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreen Company
Application
ANDA206393
Marketing category
ANDA
Marketing start
2019-05-24
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
Rxcui311975

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
0363-7971-06nicotine160 in 1 CARTONGUM, CHEWING1606
0363-7971-06nicotine1 in 1 BLISTER PACKGUM, CHEWING16
0363-7971-60nicotine1 in 1 BLISTER PACKGUM, CHEWING16
0363-7971-60nicotine20 in 1 CARTONGUM, CHEWING206
0363-7971-78nicotine1 in 1 BLISTER PACKGUM, CHEWING16
0363-7971-78nicotine100 in 1 CARTONGUM, CHEWING1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-7971-06EA - Each0363-7971ba4a8b32-37ad-42e2-ac9f-c9b53262724312022-06-06
0363-7971-78EA - Each0363-7971638e861d-077e-4606-a6a3-59be2ea921e212022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7971NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]5Current NDC, Legacy NDC, 6 package rows20250124_e5a8974f-d402-4390-8b80-b896b094a059.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNe5a8974f-d402-4390-8b80-b896b094a0596
311975nicotine 4 MG Chewing GumSCDe5a8974f-d402-4390-8b80-b896b094a0596
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYe5a8974f-d402-4390-8b80-b896b094a0596

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-7971-0600363797106160 BLISTER PACK in 1 CARTON (0363-7971-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2019-05-280000-00-00NoNoCurrent
0363-7971-600036379716020 BLISTER PACK in 1 CARTON (0363-7971-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2019-05-280000-00-00NoNoCurrent
0363-7971-7800363797178100 BLISTER PACK in 1 CARTON (0363-7971-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2019-05-240000-00-00NoNoCurrent