Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Sun Pharmaceutical industries Limited
NorthStar RxLLC
650456002
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Risedronate Sodium
Product Details
NDC Product Code
16714-870Application Number
ANDA203925Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 17, 2020METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
Risedronic acidActive
Code: OFG5EXG60LClass: ACTIBQuantity: 35 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT