Risedronate Sodium
These highlights do not include all the information needed to use RISEDRONATE SODIUM delayed-release tablets safely and effectively. See full prescribing information for RISEDRONATE SODIUM delayed-release tablets.RISEDRONATE SODIUM delayed-release tablets for oral use.Initial U.S. Approval: 1998
Approved
Approval ID
25f03627-59f2-4f35-b48b-45c551b8fa70
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2017
Manufacturers
FDA
Impax Generics
DUNS: 079832487
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
RISEDRONATE SODIUM HEMI-PENTAHYDRATE
PRODUCT DETAILS
NDC Product Code0115-1426
Application NumberANDA205066
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 30, 2017
Generic NameRISEDRONATE SODIUM HEMI-PENTAHYDRATE
INGREDIENTS (9)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
RISEDRONATE SODIUM HEMI-PENTAHYDRATEActive
Quantity: 35 mg in 1 1
Code: HU2YAQ274O
Classification: ACTIR