🇺🇸
United States · US · US:63323-378_02ac0091-573d-41ba-8b4d-5a1d42b89b2e
Octreotide
Orange BookUNIISPLATC H01CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeH01CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323378051 VIAL, MULTI-DOSE in 1 CARTON (63323-378-05) / 5 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
75R0U2568I
OCTREOTIDE ACETATE
RxCUI 221130
Orange Book
A077450
APAP
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": "63323-378_02ac0091-573d-41ba-8b4d-5a1d42b89b2e",
"productndc": "63323-378",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "077450",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 0.2MG BASE/ML",
"product_no": "001",
"approval_date": "Feb 10, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1MG BASE/ML",
"product_no": "002",
"approval_date": "Feb 10, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OCTREOTIDE ACETATE",
"proprietary_name": "Octreotide",
"active_ingred_unit": "ug/mL",
"application_number": "ANDA077450",
"marketing_category": "ANDA",
"nonproprietary_name": "OCTREOTIDE ACETATE",
"start_marketing_date": "20060314",
"active_numerator_strength": "200"
}Related drugs
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