Nicotine Polacrilex

Product NDC
0363-9330
11-digit product format
003639330
Labeler code
0363
Product ID
0363-9330_8c903d99-3418-430d-bac9-a438244b0a06
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreens
Application
ANDA078697
Marketing category
ANDA
Marketing start
2020-10-30
Marketing end
2027-09-28
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 Polacrilex

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
0363-9330-10Nicotine Polacrilex100 in 1 CARTONGUM, CHEWING1007
0363-9330-10Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING17
0363-9330-16Nicotine Polacrilex160 in 1 CARTONGUM, CHEWING1607
0363-9330-16Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING17
0363-9330-20Nicotine Polacrilex20 in 1 CARTONGUM, CHEWING207
0363-9330-20Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-9330-10EA - Each0363-9330e0822be6-599d-4feb-a628-3f2c9bd75fb612025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9330NICOTINE POLACRILEX GUM, CHEWING [WALGREENS]5Current NDC, Legacy NDC, 6 package rows20221008_826f63b2-fd18-4213-be38-a430d78897cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN826f63b2-fd18-4213-be38-a430d78897cb7
311975nicotine 4 MG Chewing GumSCD826f63b2-fd18-4213-be38-a430d78897cb7
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY826f63b2-fd18-4213-be38-a430d78897cb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9330-1000363933010100 BLISTER PACK in 1 CARTON (0363-9330-10) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2020-10-302027-09-28NoNoCurrent
0363-9330-1600363933016160 BLISTER PACK in 1 CARTON (0363-9330-16) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2020-10-302027-09-28NoNoCurrent
0363-9330-200036393302020 BLISTER PACK in 1 CARTON (0363-9330-20) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2020-10-302027-09-28NoNoCurrent