Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
USV Private Limited
USV North America Inc.
650434348
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OCTREOTIDE ACETATE
Product Details
NDC Product Code
76135-009Application Number
ANDA204669Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
February 7, 2013OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 50 ug in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
OCTREOTIDE ACETATE
Product Details
NDC Product Code
76135-011Application Number
ANDA204669Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
February 7, 2013WATERInactive
Code: 059QF0KO0RClass: IACT
OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 500 ug in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
OCTREOTIDE ACETATE
Product Details
NDC Product Code
76135-010Application Number
ANDA204669Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
February 7, 2013SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 100 ug in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL