Nicotine Polacrilex
Nicotine Polacrilex Gum 2 mg and 4 mg Coated Fruit - Rugby
Approved
Approval ID
a18dde9f-700f-4572-a6aa-577dbacdf314
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 28, 2025
Manufacturers
FDA
Lucy Goods, Inc.
DUNS: 080875415
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nicotine Polacrilex
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72224-925
Application NumberANDA079044
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicotine Polacrilex
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (15)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
NICOTINEActive
Quantity: 2 mg in 1 1
Code: 6M3C89ZY6R
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT