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United States · US · US:52958-046_dc2c72fd-ddb4-4933-8ef2-1edfbe7740f2

OCTREOTIDE ACETATE

Orange BookUNIISPLATC H01CB02

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

Identification

ManufacturerHainan Shuangcheng Pharmaceuticals Co., Ltd.
CountryUS (United States)
ATC codeH01CB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5295804610
    10 VIAL, GLASS in 1 CARTON (52958-046-10) / 1 mL in 1 VIAL, GLASS (52958-046-01)

Annotations

UNII (FDA Substance ID)
75R0U2568I
OCTREOTIDE ACETATE
RxCUI 221130
Orange Book
A217860
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": "52958-046_dc2c72fd-ddb4-4933-8ef2-1edfbe7740f2",
  "productndc": "52958-046",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "217860",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.1MG BASE/ML",
        "product_no": "001",
        "approval_date": "May 2, 2024"
      }
    ],
    "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": "ANDA217860",
  "marketing_category": "ANDA",
  "nonproprietary_name": "octreotide acetate",
  "start_marketing_date": "20240502",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code H01CB02.

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