signifor

Generic: pasireotide

Labeler: recordati rare diseases, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name signifor
Generic Name pasireotide
Labeler recordati rare diseases, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

pasireotide .9 mg/mL

Manufacturer
Recordati Rare Diseases, Inc.

Identifiers & Regulatory

Product NDC 55292-133
Product ID 55292-133_19a67a21-b599-41d1-9a7c-a5d31972d885
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200677
Listing Expiration 2027-12-31
Marketing Start 2012-12-14

Pharmacologic Class

Established (EPC)
somatostatin analog [epc]
Mechanism of Action
somatostatin receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55292133
Hyphenated Format 55292-133

Supplemental Identifiers

RxCUI
1364109 1364114 1364116 1364118 1364120 1364122
UNII
98H1T17066
NUI
N0000175904 N0000000194

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name signifor (source: ndc)
Generic Name pasireotide (source: ndc)
Application Number NDA200677 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .9 mg/mL
source: ndc
Packaging
  • 60 PACKAGE in 1 BOX (55292-133-60) / 6 AMPULE in 1 PACKAGE (55292-133-06) / 1 mL in 1 AMPULE (55292-133-01)
source: ndc

Packages (1)

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)

Ingredients (1)

pasireotide (.9 mg/mL)

Linked Drug Pages (1)

Signifor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "19a67a21-b599-41d1-9a7c-a5d31972d885", "openfda": {"nui": ["N0000175904", "N0000000194"], "unii": ["98H1T17066"], "rxcui": ["1364109", "1364114", "1364116", "1364118", "1364120", "1364122"], "spl_set_id": ["a09a25fc-a5a3-0c82-e053-2995a90a5d74"], "pharm_class_epc": ["Somatostatin Analog [EPC]"], "pharm_class_moa": ["Somatostatin Receptor Agonists [MoA]"], "manufacturer_name": ["Recordati Rare Diseases, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 PACKAGE in 1 BOX (55292-133-60)  / 6 AMPULE in 1 PACKAGE (55292-133-06)  / 1 mL in 1 AMPULE (55292-133-01)", "package_ndc": "55292-133-60", "marketing_start_date": "20121214"}], "brand_name": "Signifor", "product_id": "55292-133_19a67a21-b599-41d1-9a7c-a5d31972d885", "dosage_form": "INJECTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "55292-133", "generic_name": "pasireotide", "labeler_name": "Recordati Rare Diseases, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Signifor", "active_ingredients": [{"name": "PASIREOTIDE", "strength": ".9 mg/mL"}], "application_number": "NDA200677", "marketing_category": "NDA", "marketing_start_date": "20121214", "listing_expiration_date": "20271231"}