Octreotide Acetate
Rx Only Prescribing Information
Approved
Approval ID
6b55eedd-4160-49f8-966b-55b0e60a4b06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2018
Manufacturers
FDA
USV North America Inc.
DUNS: 964227149
Products 2
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 Code76135-005
Application NumberANDA203765
Product Classification
M
Marketing Category
C73584
G
Generic Name
Octreotide Acetate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 26, 2011
FDA Product Classification
INGREDIENTS (6)
ACETIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OCTREOTIDE ACETATEActive
Quantity: 200 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
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 Code76135-006
Application NumberANDA203765
Product Classification
M
Marketing Category
C73584
G
Generic Name
Octreotide Acetate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 26, 2011
FDA Product Classification
INGREDIENTS (6)
OCTREOTIDE ACETATEActive
Quantity: 1000 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
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT