NDC 55292-133

Signifor

Pasireotide

Signifor is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Recordati Rare Diseases, Inc.. The primary component is Pasireotide.

Product ID55292-133_a096a864-5b7d-5d34-e053-2995a90a5309
NDC55292-133
Product TypeHuman Prescription Drug
Proprietary NameSignifor
Generic NamePasireotide
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2012-12-14
Marketing CategoryNDA / NDA
Application NumberNDA200677
Labeler NameRecordati Rare Diseases, Inc.
Substance NamePASIREOTIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesSomatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 55292-133-60

60 PACKAGE in 1 BOX (55292-133-60) > 6 AMPULE in 1 PACKAGE (55292-133-06) > 1 mL in 1 AMPULE (55292-133-01)
Marketing Start Date2012-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55292-133-06 [55292013306]

Signifor INJECTION
Marketing CategoryNDA
Application NumberNDA200677
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-14

NDC 55292-133-60 [55292013360]

Signifor INJECTION
Marketing CategoryNDA
Application NumberNDA200677
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-14

NDC 55292-133-01 [55292013301]

Signifor INJECTION
Marketing CategoryNDA
Application NumberNDA200677
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-14

Drug Details

Active Ingredients

IngredientStrength
PASIREOTIDE.9 mg/mL

OpenFDA Data

SPL SET ID:a09a25fc-a5a3-0c82-e053-2995a90a5d74
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1364109
  • 1364118
  • 1364116
  • 1364114
  • 1364122
  • 1364120
  • Pharmacological Class

    • Somatostatin Analog [EPC]
    • Somatostatin Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Signifor" or generic name "Pasireotide"

    NDCBrand NameGeneric Name
    0078-0633Signiforpasireotide
    0078-0634Signiforpasireotide
    0078-0635Signiforpasireotide
    55292-131Signiforpasireotide
    55292-132Signiforpasireotide
    55292-133SigniforSignifor
    0078-0641Signifor LARpasireotide
    0078-0642Signifor LARpasireotide
    0078-0643Signifor LARpasireotide
    0078-0741Signifor LARpasireotide
    0078-0748Signifor LARpasireotide

    Trademark Results [Signifor]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SIGNIFOR
    SIGNIFOR
    79079210 3835392 Live/Registered
    Novartis AG
    2009-11-24
    SIGNIFOR
    SIGNIFOR
    78458907 3001565 Dead/Cancelled
    Novartis AG
    2004-07-29

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.