Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC
023648251
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Octreotide
Product Details
NDC Product Code
63323-376Application Number
ANDA077457Marketing Category
ANDA (C73584)Route of Administration
SUBCUTANEOUS, INTRAVENOUSEffective Date
May 11, 2021SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 100 ug in 1 mL
Octreotide
Product Details
NDC Product Code
63323-377Application Number
ANDA077457Marketing Category
ANDA (C73584)Route of Administration
SUBCUTANEOUS, INTRAVENOUSEffective Date
May 11, 2021SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 500 ug in 1 mL