Octreotide Acetate

Orange BookUNIISPLATC H01CB02

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeH01CB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0641617510
10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6175-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6175-01)

Annotations

UNII (FDA Substance ID)

75R0U2568I

OCTREOTIDE ACETATE

RxCUI 221130

Orange Book

A076313

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": "0641-6175_efa5d8e8-57ab-4b56-b8d7-f856ea97404c",
  "productndc": "0641-6175",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "076313",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.05MG BASE/ML",
        "product_no": "001",
        "approval_date": "Mar 28, 2005"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.5MG BASE/ML",
        "product_no": "002",
        "approval_date": "Mar 28, 2005"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.1MG BASE/ML",
        "product_no": "003",
        "approval_date": "Mar 28, 2005"
      }
    ],
    "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": "ANDA076313",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Octreotide Acetate",
  "start_marketing_date": "20050404",
  "active_numerator_strength": "100"
}

Related drugs

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