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United States · US · US:67457-756_e5c21813-4714-4f23-be8b-765bd58f63b3
OCTREOTIDE ACETATE
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167457756101 KIT in 1 KIT (67457-756-10) * 6 mL in 1 VIAL (67457-754-10) * 2 mL in 1 SYRINGE (67457-755-02)
Annotations
Orange Book
A216589
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"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": "67457-756_e5c21813-4714-4f23-be8b-765bd58f63b3",
"productndc": "67457-756",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "216589",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE/VIAL",
"product_no": "001",
"approval_date": "Dec 12, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE/VIAL",
"product_no": "002",
"approval_date": "Dec 12, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 30MG BASE/VIAL",
"product_no": "003",
"approval_date": "Dec 12, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "OCTREOTIDE ACETATE",
"active_ingred_unit": null,
"application_number": "ANDA216589",
"marketing_category": "ANDA",
"nonproprietary_name": "OCTREOTIDE ACETATE",
"start_marketing_date": "20260128",
"active_numerator_strength": null
}Access this data programmatically
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