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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71930-016
Application NumberANDA212589
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinidine gluonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2021
FDA Product Classification
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