OCTREOTIDE ACETATE

Orange BookUNIISPLATC H01CB02

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

CountryUS (United States)

ATC codeH01CB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2315568941
10 VIAL, GLASS in 1 CARTON (23155-689-41) / 1 mL in 1 VIAL, GLASS (23155-689-31)

Annotations

UNII (FDA Substance ID)

75R0U2568I

OCTREOTIDE ACETATE

RxCUI 221130

Orange Book

A204669

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": {
    "e5c21813-4714-4f23-be8b-765bd58f63b3": {
      "match": "brand_token",
      "title": "OCTREOTIDE ACETATE KIT [MYLAN INSTITUTIONAL LLC]",
      "spl_version": "1",
      "published_date": "2026-02-02"
    }
  },
  "productid": "23155-689_b90ce9b0-5886-4b4f-a721-9698fa28a7ec",
  "productndc": "23155-689",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "204669",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.05MG BASE/ML",
        "product_no": "001",
        "approval_date": "Dec 27, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.1MG BASE/ML",
        "product_no": "002",
        "approval_date": "Dec 27, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.5MG BASE/ML",
        "product_no": "003",
        "approval_date": "Dec 27, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OCTREOTIDE ACETATE",
  "proprietary_name": "OCTREOTIDE ACETATE",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA204669",
  "marketing_category": "ANDA",
  "nonproprietary_name": "octreotide acetate",
  "start_marketing_date": "20220525",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code H01CB02.

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