quitine nicotine

Product NDC
84720-532
11-digit product format
847200532
Labeler code
84720
Product ID
84720-532_9941d3e7-1008-4854-a6e8-605dfc210493
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
QUITINE LLC
Application
ANDA076779
Marketing category
ANDA
Marketing start
2024-12-04
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
quitine 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
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
84720-532-70quitine nicotine1 in 1 BLISTER PACKGUM, CHEWING13
84720-532-70quitine nicotine240 in 1 CARTONGUM, CHEWING2403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84720-532QUITINE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [QUITINE LLC]2Current NDC, 2 package rows20241215_302f4785-77e6-433f-83d9-d0d2618d5ef2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN302f4785-77e6-433f-83d9-d0d2618d5ef23
311975nicotine 4 MG Chewing GumSCD302f4785-77e6-433f-83d9-d0d2618d5ef23
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY302f4785-77e6-433f-83d9-d0d2618d5ef23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84720-532-7084720053270240 BLISTER PACK in 1 CARTON (84720-532-70) / 1 GUM, CHEWING in 1 BLISTER PACK240 blister pack2024-12-04NoNoCurrent