Octreotide Acetate

Orange BookSPL

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

Identification

ManufacturerTeva Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0480925708
1 KIT in 1 KIT (0480-9257-08) * 8 mL in 1 VIAL, SINGLE-DOSE (0480-9256-01) * 2 mL in 1 SYRINGE (0480-9263-21)

Annotations

Orange Book

A210317

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "INTRAMUSCULAR",
  "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": "0480-9257_2e77a034-b0ae-4694-8ac0-ae1319754d3a",
  "productndc": "0480-9257",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "210317",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Dec 5, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Octreotide Acetate",
  "active_ingred_unit": null,
  "application_number": "ANDA210317",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Octreotide Acetate",
  "start_marketing_date": "20250320",
  "active_numerator_strength": null
}

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