Octreotide Acetate
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Approved
Approval ID
2d78d5d1-77b2-4da1-98d4-d9c36e743ce2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2022
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-245
Application NumberANDA079198
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
OCTREOTIDE ACETATEActive
Quantity: 100 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
LACTIC ACID, L-Inactive
Code: F9S9FFU82N
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
octreotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-239
Application NumberANDA079198
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (5)
LACTIC ACID, L-Inactive
Code: F9S9FFU82N
Classification: IACT
OCTREOTIDE ACETATEActive
Quantity: 50 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
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 Code67457-246
Application NumberANDA079198
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
OCTREOTIDE ACETATEActive
Quantity: 500 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
LACTIC ACID, L-Inactive
Code: F9S9FFU82N
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT