Signifor
These highlights do not include all the information needed to use SIGNIFOR safely and effectively. See full prescribing information for SIGNIFOR. SIGNIFOR (pasireotide) injection, for subcutaneous use Initial U.S. Approval: 2012
Approved
Approval ID
a09a25fc-a5a3-0c82-e053-2995a90a5d74
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2023
Manufacturers
FDA
Recordati Rare Diseases, Inc.
DUNS: 181699406
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pasireotide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55292-132
Application NumberNDA200677
Product Classification
M
Marketing Category
C73594
G
Generic Name
pasireotide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 3, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Quantity: 4.2 mg in 1 mL
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TARTARIC ACIDInactive
Quantity: 1.501 mg in 1 mL
Code: W4888I119H
Classification: IACT
PASIREOTIDEActive
Quantity: 0.6 mg in 1 mL
Code: 98H1T17066
Classification: ACTIB
pasireotide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55292-131
Application NumberNDA200677
Product Classification
M
Marketing Category
C73594
G
Generic Name
pasireotide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 3, 2023
FDA Product Classification
INGREDIENTS (5)
TARTARIC ACIDInactive
Quantity: 1.501 mg in 1 mL
Code: W4888I119H
Classification: IACT
SODIUM HYDROXIDEInactive
Quantity: 4.2 mg in 1 mL
Code: 55X04QC32I
Classification: IACT
PASIREOTIDEActive
Quantity: 0.3 mg in 1 mL
Code: 98H1T17066
Classification: ACTIB
MANNITOLInactive
Quantity: 49.5 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
pasireotide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55292-133
Application NumberNDA200677
Product Classification
M
Marketing Category
C73594
G
Generic Name
pasireotide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 3, 2023
FDA Product Classification
INGREDIENTS (5)
MANNITOLInactive
Quantity: 49.5 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
TARTARIC ACIDInactive
Quantity: 1.501 mg in 1 mL
Code: W4888I119H
Classification: IACT
SODIUM HYDROXIDEInactive
Quantity: 4.2 mg in 1 mL
Code: 55X04QC32I
Classification: IACT
PASIREOTIDEActive
Quantity: 0.9 mg in 1 mL
Code: 98H1T17066
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT