Nicotine Polacrilex
Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - Equate
Approved
Approval ID
4af800f9-bcb3-4320-8d32-f1bfd54ee5e9
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Jan 29, 2025
Manufacturers
FDA
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
DUNS: 068331990
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 Code55910-976
Application NumberANDA078697
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicotine Polacrilex
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2025
FDA Product Classification
INGREDIENTS (12)
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
NICOTINEActive
Quantity: 4 mg in 1 1
Code: 6M3C89ZY6R
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT