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United States · US · US:0078-0180_ad42b59d-8ad5-4855-96a9-f40c7ef4a7e3

Sandostatin

Orange BookUNIISPLATC H01CB02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeH01CB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0078018001
    10 AMPULE in 1 PACKAGE (0078-0180-01) / 1 mL in 1 AMPULE (0078-0180-61)

Annotations

UNII (FDA Substance ID)
75R0U2568I
OCTREOTIDE ACETATE
RxCUI 221130
Orange Book
N019667
APAPAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "75R0U2568I",
    "rxcui": "221130",
    "inchikey": "QWFYIFWTVZFPRY-LODIGNQBSA-N",
    "display_name": "OCTREOTIDE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9": {
      "match": "brand_token",
      "title": "SANDOSTATIN LAR DEPOT (OCTREOTIDE ACETATE) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "29",
      "published_date": "2025-12-23"
    }
  },
  "productid": "0078-0180_ad42b59d-8ad5-4855-96a9-f40c7ef4a7e3",
  "productndc": "0078-0180",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019667",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 0.05MG BASE/ML",
        "product_no": "001",
        "approval_date": "Oct 21, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 0.1MG BASE/ML",
        "product_no": "002",
        "approval_date": "Oct 21, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 0.5MG BASE/ML",
        "product_no": "003",
        "approval_date": "Oct 21, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Jun 12, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Jun 12, 1991"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OCTREOTIDE ACETATE",
  "proprietary_name": "Sandostatin",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA019667",
  "marketing_category": "NDA",
  "nonproprietary_name": "octreotide acetate",
  "start_marketing_date": "19881021",
  "active_numerator_strength": "50"
}

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