Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Dr. Reddy's Laboratories Limited - FTO III
Dr. Reddy's Laboratories Limited
918608162
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibandronate sodium
Product Details
NDC Product Code
55111-575Application Number
ANDA078997Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 30, 2023IbandronateActive
Code: J12U072QL0Class: ACTIMQuantity: 150 mg in 1 1
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
sodium stearyl fumarateInactive
Code: 7CV7WJK4UIClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polyethylene glycol 400Inactive
Code: B697894SGQClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
shellacInactive
Code: 46N107B71OClass: IACT