NICOTINE

Product NDC
50090-6674
11-digit product format
500906674
Labeler code
50090
Product ID
50090-6674_ca422a23-5511-4c92-9d36-a45faba469a4
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206393
Marketing category
ANDA
Marketing start
2023-08-14
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6674-0NICOTINE110 in 1 CARTONGUM, CHEWING1103
50090-6674-0NICOTINE1 in 1 BLISTER PACKGUM, CHEWING13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6674-0EA - Each50090-6674390fdec2-8517-4cce-85bf-4962f525ed9012026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6674NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240105_83b3b56e-0081-41df-818c-bccc4a996b7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN83b3b56e-0081-41df-818c-bccc4a996b7f3
311975nicotine 4 MG Chewing GumSCD83b3b56e-0081-41df-818c-bccc4a996b7f3
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY83b3b56e-0081-41df-818c-bccc4a996b7f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6674-0500906674001 CARTON in 1 BLISTER PACK (50090-6674-0) / 110 GUM, CHEWING in 1 CARTON1 carton2023-12-28NoNoHistorical