NDC 0078-0635

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 ID: 0078-0635_0ccb917e-89ea-477c-86f2-0335af5202ba
• NDC: 0078-0635
• 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: Novartis Pharmaceuticals Corporation
• Substance Name: PASIREOTIDE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0635-20

60 PACKAGE in 1 BOX (0078-0635-20) > 6 AMPULE in 1 PACKAGE (0078-0635-06) > 1 mL in 1 AMPULE (0078-0635-61)

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

NDC SPL Data Element Entries

NDC 0078-0635-61 [00078063561]

Signifor INJECTION

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

NDC 0078-0635-20 [00078063520]

Signifor INJECTION

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

NDC 0078-0635-06 [00078063506]

Signifor INJECTION

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

Drug Details

Active Ingredients

Ingredient	Strength
PASIREOTIDE	.9 mg/mL

OpenFDA Data

• SPL SET ID: 442f0d9d-5c7d-4b81-b329-d71be8cf2be2
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• 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