🇺🇸
United States · US · US:68462-896_1a5d8576-7695-42f0-871a-d8de8c7b0220
Octreotide Acetate
Orange BookUNIISPLATC H01CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGLENMARK PHARMACEUTICALS INC., USA
CountryUS (United States)
ATC codeH01CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11684628961010 VIAL in 1 CARTON (68462-896-10) / 1 mL in 1 VIAL (68462-896-01)
Annotations
UNII (FDA Substance ID)
75R0U2568I
OCTREOTIDE ACETATE
RxCUI 221130
Orange Book
A216839
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": "68462-896_1a5d8576-7695-42f0-871a-d8de8c7b0220",
"productndc": "68462-896",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "216839",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 0.5MG BASE/ML",
"product_no": "001",
"approval_date": "Jun 22, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 0.1MG BASE/ML",
"product_no": "002",
"approval_date": "Jun 22, 2023"
}
],
"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": "ANDA216839",
"marketing_category": "ANDA",
"nonproprietary_name": "Octreotide Acetate",
"start_marketing_date": "20230809",
"active_numerator_strength": "100"
}Related drugs
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