signifor lar

Generic: pasireotide

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

Drug Facts

Product Profile

Brand Name signifor lar
Generic Name pasireotide
Labeler recordati rare diseases, inc.
Dosage Form KIT
Manufacturer
Recordati Rare Diseases, Inc.

Identifiers & Regulatory

Product NDC 55292-139
Product ID 55292-139_fb5687ef-6bbc-4ac4-899e-46c941f214c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203255
Listing Expiration 2026-12-31
Marketing Start 2014-12-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55292139
Hyphenated Format 55292-139

Supplemental Identifiers

RxCUI
1597596 1597599 1597601 1597603 1597820 1597822 2049730 2049732 2049734 2049736

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 lar (source: ndc)
Generic Name pasireotide (source: ndc)
Application Number NDA203255 (source: ndc)

Resolved Composition

Strengths
  • 10 mg
  • 20 mg
  • 30 mg
  • 40 mg
  • 60 mg
  • 2 ml
  • 20 g
  • 10 mg/2 ml
  • 5 mg/ml
  • 20 mg/2 ml
  • 10 mg/ml
  • 30 mg/2 ml
  • 15 mg/ml
  • 40 mg/2 ml
  • 20 mg/ml
  • 60 mg/2 ml
  • 30 mg/ml
source: label
Packaging
  • 1 KIT in 1 KIT (55292-139-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-134-01) * 2 mL in 1 SYRINGE
source: ndc

Packages (1)

55292-139-01 1 KIT in 1 KIT (55292-139-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-134-01) * 2 mL in 1 SYRINGE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Signifor LAR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "fb5687ef-6bbc-4ac4-899e-46c941f214c5", "openfda": {"rxcui": ["1597596", "1597599", "1597601", "1597603", "1597820", "1597822", "2049730", "2049732", "2049734", "2049736"], "spl_set_id": ["a0aad470-3f38-af97-e053-2995a90a383a"], "manufacturer_name": ["Recordati Rare Diseases, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 KIT (55292-139-01)  *  6 mL in 1 VIAL, SINGLE-USE (55292-134-01)  *  2 mL in 1 SYRINGE", "package_ndc": "55292-139-01", "marketing_start_date": "20180629"}], "brand_name": "Signifor LAR", "product_id": "55292-139_fb5687ef-6bbc-4ac4-899e-46c941f214c5", "dosage_form": "KIT", "product_ndc": "55292-139", "generic_name": "pasireotide", "labeler_name": "Recordati Rare Diseases, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Signifor LAR", "application_number": "NDA203255", "marketing_category": "NDA", "marketing_start_date": "20141215", "listing_expiration_date": "20261231"}