SOMATULINE DEPOT

Orange BookUNIISPLATC H01CB03

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

Identification

ManufacturerIpsen Biopharmaceuticals, Inc.

CountryUS (United States)

ATC codeH01CB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1505410604
1 POUCH in 1 CARTON (15054-1060-4) / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

IEU56G3J9C

LANREOTIDE ACETATE

RxCUI 236167

Orange Book

N022074

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "IEU56G3J9C",
    "rxcui": "236167",
    "inchikey": null,
    "display_name": "LANREOTIDE ACETATE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "6e4a41fd-a753-4362-87ee-8cc56ed3660d": {
      "match": "brand_token",
      "title": "SOMATULINE DEPOT (LANREOTIDE ACETATE) INJECTION [IPSEN BIOPHARMACEUTICALS, INC.]",
      "spl_version": "16",
      "published_date": "2024-10-17"
    }
  },
  "productid": "15054-1060_1cafe88a-b7a2-42ff-bb99-3dd17538c58b",
  "productndc": "15054-1060",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "022074",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)",
        "product_no": "001",
        "approval_date": "Aug 30, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)",
        "product_no": "002",
        "approval_date": "Aug 30, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)",
        "product_no": "003",
        "approval_date": "Aug 30, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LANREOTIDE ACETATE",
  "proprietary_name": "SOMATULINE DEPOT",
  "active_ingred_unit": "mg/.2mL",
  "application_number": "NDA022074",
  "marketing_category": "NDA",
  "nonproprietary_name": "lanreotide acetate",
  "start_marketing_date": "20071114",
  "active_numerator_strength": "60"
}

Related drugs

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