Octreotide Acetate
Octreotide Acetate Injection(For Subcutaneous or Intravenous Use)
Approved
Approval ID
7ce2fc1e-7520-4d04-be45-2baba32ca24a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 7, 2023
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 796852890
Products 5
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 Code25021-467
Application NumberANDA091041
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateMarch 7, 2023
FDA Product Classification
INGREDIENTS (6)
octreotide acetateActive
Quantity: 1000 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
phenolInactive
Code: 339NCG44TV
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
octreotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-466
Application NumberANDA091041
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateMarch 7, 2023
FDA Product Classification
INGREDIENTS (6)
octreotide acetateActive
Quantity: 200 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
phenolInactive
Code: 339NCG44TV
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
octreotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-465
Application NumberANDA090834
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateMarch 7, 2023
FDA Product Classification
INGREDIENTS (5)
octreotide acetateActive
Quantity: 500 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
octreotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-464
Application NumberANDA090834
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateMarch 7, 2023
FDA Product Classification
INGREDIENTS (5)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
octreotide acetateActive
Quantity: 100 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
octreotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-463
Application NumberANDA090834
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateMarch 7, 2023
FDA Product Classification
INGREDIENTS (5)
octreotide acetateActive
Quantity: 50 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT