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United States · US · US:0480-9262_2e77a034-b0ae-4694-8ac0-ae1319754d3a
Octreotide Acetate
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104809262081 KIT in 1 KIT (0480-9262-08) * 8 mL in 1 VIAL, SINGLE-DOSE (0480-9260-01) * 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": "0480-9262_2e77a034-b0ae-4694-8ac0-ae1319754d3a",
"productndc": "0480-9262",
"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": "20241001",
"active_numerator_strength": null
}Access this data programmatically
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