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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54738-901
Application NumberANDA089338
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinidine Gluconate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 6, 2019
FDA Product Classification
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