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United States · US · US:0078-0825_2a2ad59f-21cd-4734-9c4b-0154e9db1642

Sandostatin LAR Depot

Orange BookSPL

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

Identification

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

Packs · 1

  • ndc11
    0078082581
    1 KIT in 1 KIT (0078-0825-81) * 2 mL in 1 SYRINGE * 6 mL in 1 VIAL (0078-0804-61)

Annotations

Orange Book
N021008
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "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": "0078-0825_2a2ad59f-21cd-4734-9c4b-0154e9db1642",
  "productndc": "0078-0825",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "021008",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Nov 25, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 20MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Nov 25, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 30MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Nov 25, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Sandostatin LAR Depot",
  "active_ingred_unit": null,
  "application_number": "NDA021008",
  "marketing_category": "NDA",
  "nonproprietary_name": "octreotide acetate",
  "start_marketing_date": "20160722",
  "active_numerator_strength": null
}

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