Quinidine Gluconate
QUINIDINE GLUCONATE EXTENDED-RELEASE TABLETS USP
Approved
Approval ID
4fb02ad7-6e93-4aff-9aca-5162559b99a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 6, 2019
Manufacturers
FDA
Richmond Pharmaceuticals, Inc.
DUNS: 043569607
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Quinidine Gluconate
PRODUCT DETAILS
NDC Product Code54738-901
Application NumberANDA089338
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 6, 2019
Generic NameQuinidine Gluconate
INGREDIENTS (8)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
Quinidine GluconateActive
Quantity: 324 mg in 1 1
Code: R6875N380F
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hypromellose 2208 (15000 mpa.s)Inactive
Code: Z78RG6M2N2
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
sodium alginateInactive
Code: C269C4G2ZQ
Classification: IACT