Signifor LAR

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerRecordati Rare Diseases, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5529214001
1 KIT in 1 KIT (55292-140-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-135-01) * 2 mL in 1 SYRINGE

Annotations

Orange Book

N203255

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "a09a25fc-a5a3-0c82-e053-2995a90a5d74": {
      "match": "brand_token",
      "title": "SIGNIFOR (PASIREOTIDE) INJECTION [RECORDATI RARE DISEASES, INC.]",
      "spl_version": "20",
      "published_date": "2026-02-18"
    }
  },
  "productid": "55292-140_fb5687ef-6bbc-4ac4-899e-46c941f214c5",
  "productndc": "55292-140",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "203255",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 15, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 40MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Dec 15, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 60MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Dec 15, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE/VIAL",
        "product_no": "004",
        "approval_date": "Jun 29, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE/VIAL",
        "product_no": "005",
        "approval_date": "Jun 29, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Signifor LAR",
  "active_ingred_unit": null,
  "application_number": "NDA203255",
  "marketing_category": "NDA",
  "nonproprietary_name": "pasireotide",
  "start_marketing_date": "20141215",
  "active_numerator_strength": null
}

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