NDC 0078-0634

Signifor

Pasireotide

Signifor is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Pasireotide.

Product ID0078-0634_0ccb917e-89ea-477c-86f2-0335af5202ba
NDC0078-0634
Product TypeHuman Prescription Drug
Proprietary NameSignifor
Generic NamePasireotide
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2012-12-14
Marketing CategoryNDA / NDA
Application NumberNDA200677
Labeler NameNovartis Pharmaceuticals Corporation
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 0078-0634-20

60 PACKAGE in 1 BOX (0078-0634-20) > 6 AMPULE in 1 PACKAGE (0078-0634-06) > 1 mL in 1 AMPULE (0078-0634-61)
Marketing Start Date2012-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0634-61 [00078063461]

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

NDC 0078-0634-20 [00078063420]

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

NDC 0078-0634-06 [00078063406]

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

Drug Details

Active Ingredients

IngredientStrength
PASIREOTIDE.6 mg/mL

OpenFDA Data

SPL SET ID:442f0d9d-5c7d-4b81-b329-d71be8cf2be2
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

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