Nicotine
Meijer Distribution, Inc. Nicotine Gum Drug Facts
Approved
Approval ID
6d86cb8f-018e-41be-a6d0-9ca30e731855
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Feb 18, 2025
Manufacturers
FDA
Meijer Distribution Inc
DUNS: 006959555
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 Code41250-456
Application NumberANDA076777
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicotine Polacrilex
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2025
FDA Product Classification
INGREDIENTS (13)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
NICOTINEActive
Quantity: 2 mg in 1 1
Code: 6M3C89ZY6R
Classification: ACTIB
POLACRILINInactive
Code: RCZ785HI7S
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT