Quinidine gluconate
Rx Only QUINIDINE GLUCONATE EXTENDED-RELEASE TABLETS USP
Approved
Approval ID
4db375a3-0cff-4fa7-af7a-2a49e0b922d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2021
Manufacturers
FDA
Eywa Pharma Inc
DUNS: 080465609
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Quinidine gluonate
PRODUCT DETAILS
NDC Product Code71930-016
Application NumberANDA212589
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 29, 2021
Generic NameQuinidine gluonate
INGREDIENTS (8)
QUINIDINE GLUCONATEActive
Quantity: 324 mg in 1 1
Code: R6875N380F
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT