Nicotine
Meijer Distribution, Inc. Nicotine Lozenge Drug Facts
Approved
Approval ID
5bd02b68-84a2-43f1-9f01-fc4b8967e98a
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 1, 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 Code41250-424
Application NumberANDA090821
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicotine Polacrilex
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2025
FDA Product Classification
INGREDIENTS (10)
NICOTINEActive
Quantity: 4 mg in 1 1
Code: 6M3C89ZY6R
Classification: ACTIB
POLACRILINInactive
Code: RCZ785HI7S
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBN
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT