Nicotine

Product NDC
63739-371
11-digit product format
637390371
Labeler code
63739
Product ID
63739-371_da34496a-ee93-4b80-b2b4-6baf28a4d651
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA074507
Marketing category
ANDA
Marketing start
2020-04-27
Marketing end
2026-12-31
Substance
NICOTINE
Active strength
2 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
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

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
63739-371-63Nicotine1 in 1 BLISTER PACKGUM, CHEWING14
63739-371-63Nicotine110 in 1 CARTONGUM, CHEWING1104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-371NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON CORPORATION DBA SKY PACKAGING]3Current NDC, Legacy NDC, 2 package rows20250130_9ac37719-24c2-4ec7-9fb3-6408d8a5fc7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN9ac37719-24c2-4ec7-9fb3-6408d8a5fc7a4
314119nicotine 2 MG Chewing GumSCD9ac37719-24c2-4ec7-9fb3-6408d8a5fc7a4
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY9ac37719-24c2-4ec7-9fb3-6408d8a5fc7a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-371-6363739037163110 BLISTER PACK in 1 CARTON (63739-371-63) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2020-04-272026-12-31NoNoCurrent