Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sandostatin
Product Details
NDC Product Code
0078-0182Application Number
NDA019667Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 3, 2023LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACTQuantity: 3.4 mg in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 500 ug in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 45 mg in 1 mL
Sandostatin
Product Details
NDC Product Code
0078-0181Application Number
NDA019667Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 3, 2023OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 100 ug in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 45 mg in 1 mL
LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACTQuantity: 3.4 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
Sandostatin
Product Details
NDC Product Code
0078-0180Application Number
NDA019667Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 3, 2023OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 50 ug in 1 mL
LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACTQuantity: 3.4 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 45 mg in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT