Octreotide acetate
Octreotide Acetate Injection
Approved
Approval ID
dec280fa-6646-4cfe-916e-5f3485378050
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2012
Manufacturers
FDA
Wockhardt Limited
DUNS: 650069115
Products 1
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 Code55648-632
Application NumberANDA090986
Product Classification
M
Marketing Category
C73584
G
Generic Name
Octreotide acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateSeptember 13, 2012
FDA Product Classification
INGREDIENTS (6)
OCTREOTIDE ACETATEActive
Quantity: 1000 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT