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 useInitial U.S. Approval: 1998
Approved
Approval ID
1d9e520b-2fa6-4603-b397-f0fc24fae775
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2020
Manufacturers
FDA
Sun Pharmaceutical Industires Inc.
DUNS: 146974886
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 Code63304-440
Application NumberANDA203925
Product Classification
M
Marketing Category
C73584
G
Generic Name
RISEDRONATE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2020
FDA Product Classification
INGREDIENTS (16)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
RISEDRONATE SODIUMActive
Quantity: 35 mg in 1 1
Code: OFG5EXG60L
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT