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FDA Approval

Octreotide Acetate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Sagent Pharmaceuticals
DUNS: 796852890
Effective Date
March 7, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Octreotide(1000 ug in 1 mL)

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Octreotide Acetate

Product Details

NDC Product Code
25021-467
Application Number
ANDA091041
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS, INTRAVENOUS
Effective Date
March 7, 2023
Code: 75R0U2568IClass: ACTIMQuantity: 1000 ug in 1 mL
phenolInactive
Code: 339NCG44TVClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
acetic acidInactive
Code: Q40Q9N063PClass: IACT
sodium acetateInactive
Code: 4550K0SC9BClass: IACT

Octreotide Acetate

Product Details

NDC Product Code
25021-466
Application Number
ANDA091041
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS, INTRAVENOUS
Effective Date
March 7, 2023
Code: 75R0U2568IClass: ACTIMQuantity: 200 ug in 1 mL
phenolInactive
Code: 339NCG44TVClass: IACT
sodium acetateInactive
Code: 4550K0SC9BClass: IACT
acetic acidInactive
Code: Q40Q9N063PClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT

Octreotide Acetate

Product Details

NDC Product Code
25021-465
Application Number
ANDA090834
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS, INTRAVENOUS
Effective Date
March 7, 2023
Code: 75R0U2568IClass: ACTIMQuantity: 500 ug in 1 mL
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
sodium acetateInactive
Code: 4550K0SC9BClass: IACT
acetic acidInactive
Code: Q40Q9N063PClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT

Octreotide Acetate

Product Details

NDC Product Code
25021-464
Application Number
ANDA090834
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS, INTRAVENOUS
Effective Date
March 7, 2023
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
Code: 75R0U2568IClass: ACTIMQuantity: 100 ug in 1 mL
waterInactive
Code: 059QF0KO0RClass: IACT
sodium acetateInactive
Code: 4550K0SC9BClass: IACT
acetic acidInactive
Code: Q40Q9N063PClass: IACT

Octreotide Acetate

Product Details

NDC Product Code
25021-463
Application Number
ANDA090834
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS, INTRAVENOUS
Effective Date
March 7, 2023
Code: 75R0U2568IClass: ACTIMQuantity: 50 ug in 1 mL
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
sodium acetateInactive
Code: 4550K0SC9BClass: IACT
acetic acidInactive
Code: Q40Q9N063PClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
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