OCTREOTIDE ACETATE
Rx ONLY
Approved
Approval ID
ad30bb58-5e16-43c4-8fdc-5cef8261eb8f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 7, 2019
Manufacturers
FDA
USV North America Inc.
DUNS: 964227149
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OCTREOTIDE ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76135-009
Application NumberANDA204669
Product Classification
M
Marketing Category
C73584
G
Generic Name
OCTREOTIDE ACETATE
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 7, 2013
FDA Product Classification
INGREDIENTS (5)
OCTREOTIDE ACETATEActive
Quantity: 50 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
ACETIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OCTREOTIDE ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76135-011
Application NumberANDA204669
Product Classification
M
Marketing Category
C73584
G
Generic Name
OCTREOTIDE ACETATE
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 7, 2013
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OCTREOTIDE ACETATEActive
Quantity: 500 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
ACETIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
OCTREOTIDE ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76135-010
Application NumberANDA204669
Product Classification
M
Marketing Category
C73584
G
Generic Name
OCTREOTIDE ACETATE
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 7, 2013
FDA Product Classification
INGREDIENTS (5)
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OCTREOTIDE ACETATEActive
Quantity: 100 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
ACETIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT