Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aurobindo Pharma Limited
AuroMedics Pharma LLC
918917626
Eugia Pharma Specialities Limited
AuroMedics Pharma LLC
650498244
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
55150-191Application Number
ANDA205332Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
May 5, 2022IbandronateActive
Code: J12U072QL0Class: ACTIMQuantity: 3 mg in 3 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT