Signifor

Orange BookUNIISPLATC H01CB05

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

Identification

ManufacturerRecordati Rare Diseases, Inc.

CountryUS (United States)

ATC codeH01CB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5529213160
60 PACKAGE in 1 BOX (55292-131-60) / 6 AMPULE in 1 PACKAGE (55292-131-06) / 1 mL in 1 AMPULE (55292-131-01)

Annotations

UNII (FDA Substance ID)

98H1T17066

PASIREOTIDE

RxCUI 1364105

Orange Book

N200677

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "98H1T17066",
    "rxcui": "1364105",
    "inchikey": "VMZMNAABQBOLAK-DBILLSOUSA-N",
    "display_name": "PASIREOTIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "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": "55292-131_19a67a21-b599-41d1-9a7c-a5d31972d885",
  "productndc": "55292-131",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "200677",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Dec 14, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Dec 14, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Dec 14, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PASIREOTIDE",
  "proprietary_name": "Signifor",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA200677",
  "marketing_category": "NDA",
  "nonproprietary_name": "pasireotide",
  "start_marketing_date": "20121214",
  "active_numerator_strength": ".3"
}

Related drugs

Other records sharing ATC code H01CB05.

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