AMAZON BASIC CARE NICOTINE POLACRILEX
Approved
Approval ID
10ece1fa-f4c2-42ad-e063-6394a90a3a7d
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 2, 2025
Manufacturers
FDA
Amazon.com Services LLC
DUNS: 128990418
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 Code72288-266
Application NumberANDA213266
Product Classification
M
Marketing Category
C73584
G
Generic Name
NICOTINE POLACRILEX
Product Specifications
Route of AdministrationORAL
Effective DateMay 2, 2025
FDA Product Classification
INGREDIENTS (13)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CALCIUM POLYCARBOPHILInactive
Code: 8F049NKY49
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBN
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
NICOTINEActive
Quantity: 4 mg in 1 1
Code: 6M3C89ZY6R
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ICODEXTRINInactive
Code: 2NX48Z0A9G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT