NDC 55292-131

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 ID: 55292-131_a096a864-5b7d-5d34-e053-2995a90a5309
• NDC: 55292-131
• Product Type: Human Prescription Drug
• Proprietary Name: Signifor
• Generic Name: Pasireotide
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2012-12-14
• Marketing Category: NDA / NDA
• Application Number: NDA200677
• Labeler Name: Recordati Rare Diseases, Inc.
• Substance Name: PASIREOTIDE
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 55292-131-60

60 PACKAGE in 1 BOX (55292-131-60) > 6 AMPULE in 1 PACKAGE (55292-131-06) > 1 mL in 1 AMPULE (55292-131-01)

• Marketing Start Date: 2012-12-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55292-131-01 [55292013101]

Signifor INJECTION

• Marketing Category: NDA
• Application Number: NDA200677
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-12-14

NDC 55292-131-06 [55292013106]

Signifor INJECTION

• Marketing Category: NDA
• Application Number: NDA200677
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-12-14

NDC 55292-131-60 [55292013160]

Signifor INJECTION

• Marketing Category: NDA
• Application Number: NDA200677
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-12-14

Drug Details

Active Ingredients

Ingredient	Strength
PASIREOTIDE	.3 mg/mL

OpenFDA Data

• SPL SET ID: a09a25fc-a5a3-0c82-e053-2995a90a5d74
• Manufacturer:
  • Recordati Rare Diseases, Inc.
• UNII:
  • 98H1T17066
• 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"

NDC	Brand Name	Generic Name
0078-0633	Signifor	pasireotide
0078-0634	Signifor	pasireotide
0078-0635	Signifor	pasireotide
55292-131	Signifor	pasireotide
55292-132	Signifor	pasireotide
55292-133	Signifor	Signifor
0078-0641	Signifor LAR	pasireotide
0078-0642	Signifor LAR	pasireotide
0078-0643	Signifor LAR	pasireotide
0078-0741	Signifor LAR	pasireotide
0078-0748	Signifor LAR	pasireotide