Risedronate Sodium
These highlights do not include all the information needed to use RISEDRONATE SODIUM DELAYED-RELEASE safely and effectively. See full prescribing information for RISEDRONATE SODIUM DELAYED-RELEASE . RISEDRONATE SODIUM DELAYED-RELEASE tablets Initial U.S. Approval: 1998
Approved
Approval ID
c89430be-15f1-4b8b-ab7e-738de716ee7d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2023
Manufacturers
FDA
Greenstone LLC
DUNS: 825560733
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
risedronate sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59762-0407
Application NumberNDA022560
Product Classification
M
Marketing Category
C73605
G
Generic Name
risedronate sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (13)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
RISEDRONATE SODIUM MONOHYDRATEActive
Quantity: 4.9 mg in 1 1
Code: F67L43UT5C
Classification: ACTIR
RISEDRONATE SODIUM HEMI-PENTAHYDRATEActive
Quantity: 30.1 mg in 1 1
Code: HU2YAQ274O
Classification: ACTIR