🇺🇸
United States · US · US:0641-6177_efa5d8e8-57ab-4b56-b8d7-f856ea97404c
Octreotide Acetate
Orange BookUNIISPLATC H01CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeH01CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1106416177011 VIAL, MULTI-DOSE in 1 CARTON (0641-6177-01) / 5 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
75R0U2568I
OCTREOTIDE ACETATE
RxCUI 221130
Orange Book
A076330
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": "0641-6177_efa5d8e8-57ab-4b56-b8d7-f856ea97404c",
"productndc": "0641-6177",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "076330",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 0.2MG BASE/ML",
"product_no": "001",
"approval_date": "Apr 8, 2005"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 1MG BASE/ML",
"product_no": "002",
"approval_date": "Apr 8, 2005"
}
],
"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": "ANDA076330",
"marketing_category": "ANDA",
"nonproprietary_name": "Octreotide Acetate",
"start_marketing_date": "20050408",
"active_numerator_strength": "200"
}Related drugs
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