Lanreotide Acetate

Orange BookUNIISPLATC H01CB03

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

Identification

ManufacturerCipla USA Inc.

CountryUS (United States)

ATC codeH01CB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6909789067
1 SYRINGE in 1 CARTON (69097-890-67) / .3 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

IEU56G3J9C

LANREOTIDE ACETATE

RxCUI 236167

Orange Book

N215395

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": "69097-890_fd205110-15eb-4707-82b2-185e5bbf616b",
  "productndc": "69097-890",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215395",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)",
        "product_no": "001",
        "approval_date": "Dec 17, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)",
        "product_no": "002",
        "approval_date": "Dec 17, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)",
        "product_no": "003",
        "approval_date": "Dec 17, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LANREOTIDE ACETATE",
  "proprietary_name": "Lanreotide Acetate",
  "active_ingred_unit": "mg/.3mL",
  "application_number": "NDA215395",
  "marketing_category": "NDA",
  "nonproprietary_name": "lanreotide acetate",
  "start_marketing_date": "20211224",
  "active_numerator_strength": "90"
}

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