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United States · US · US:61269-565_45add4e4-7806-4a6c-b360-e6e383d7e18e
ORLISTAT
Orange BookUNIISPLATC A08AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH2-Pharma LLC
CountryUS (United States)
ATC codeA08AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11612695659090 CAPSULE in 1 BOTTLE, PLASTIC (61269-565-90)
Annotations
UNII (FDA Substance ID)
95M8R751W8
ORLISTAT
RxCUI 37925
Orange Book
N020766
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "95M8R751W8",
"rxcui": "37925",
"inchikey": "AHLBNYSZXLDEJQ-FWEHEUNISA-N",
"display_name": "ORLISTAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f81dfaeb-46d5-47ce-9ef6-19259f5ac61c": {
"match": "brand_token",
"title": "ORLISTAT CAPSULE [H2-PHARMA LLC]",
"spl_version": "7",
"published_date": "2026-01-12"
}
},
"productid": "61269-565_45add4e4-7806-4a6c-b360-e6e383d7e18e",
"productndc": "61269-565",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "020766",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "120MG",
"product_no": "001",
"approval_date": "Apr 23, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ORLISTAT",
"proprietary_name": "ORLISTAT",
"active_ingred_unit": "mg/1",
"application_number": "NDA020766",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "orlistat",
"start_marketing_date": "20220601",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code A08AB01.
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