🇺🇸
United States · US · US:25021-465_5e508c59-4170-441a-a94a-70b0bf28b8e4
Octreotide Acetate
Orange BookUNIISPLATC H01CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeH01CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11250214650110 VIAL in 1 CARTON (25021-465-01) / 1 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
75R0U2568I
OCTREOTIDE ACETATE
RxCUI 221130
Orange Book
A090834
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": "25021-465_5e508c59-4170-441a-a94a-70b0bf28b8e4",
"productndc": "25021-465",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "090834",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 0.05MG BASE/ML",
"product_no": "001",
"approval_date": "Nov 12, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 0.1MG BASE/ML",
"product_no": "002",
"approval_date": "Nov 12, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 0.5MG BASE/ML",
"product_no": "003",
"approval_date": "Nov 12, 2013"
}
],
"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": "ANDA090834",
"marketing_category": "ANDA",
"nonproprietary_name": "octreotide acetate",
"start_marketing_date": "20230615",
"active_numerator_strength": "500"
}Related drugs
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