Octreotide
Octreotide Acetate Injection
Approved
Approval ID
d6a9a800-889d-417f-b533-1913197d0022
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code63323-376
Application NumberANDA077457
Product Classification
M
Marketing Category
C73584
G
Generic Name
OCTREOTIDE ACETATE
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateMay 11, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
OCTREOTIDE ACETATEActive
Quantity: 100 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
OCTREOTIDE ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-377
Application NumberANDA077457
Product Classification
M
Marketing Category
C73584
G
Generic Name
OCTREOTIDE ACETATE
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateMay 11, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
OCTREOTIDE ACETATEActive
Quantity: 500 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM