LANREOTIDE ACETATE

Orange BookUNIISPLATC H01CB03

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

Identification

ManufacturerEXELAN PHARMACEUTICALS, INC.

CountryUS (United States)

ATC codeH01CB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7628272067
1 POUCH in 1 CARTON (76282-720-67) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

IEU56G3J9C

LANREOTIDE ACETATE

RxCUI 236167

Orange Book

A217193

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": {
    "2892b4c3-0329-4d29-97ff-3b45283bbab1": {
      "match": "brand_token",
      "title": "LANREOTIDE ACETATE INJECTION [CIPLA USA INC.]",
      "spl_version": "3",
      "published_date": "2025-06-02"
    }
  },
  "productid": "76282-720_054af266-c850-45c8-b027-d810d7d5f0ae",
  "productndc": "76282-720",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "217193",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)",
        "product_no": "001",
        "approval_date": "May 21, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)",
        "product_no": "002",
        "approval_date": "May 21, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)",
        "product_no": "003",
        "approval_date": "May 21, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LANREOTIDE ACETATE",
  "proprietary_name": "LANREOTIDE ACETATE",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "ANDA217193",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LANREOTIDE ACETATE",
  "start_marketing_date": "20250530",
  "active_numerator_strength": "120"
}

Related drugs

Other records sharing ATC code H01CB03.

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