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United States · US · US:0135-0461_4d51b8f1-a819-7ff6-e063-6294a90a82bc
ALLI
Orange BookUNIISPLATC A08AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeA08AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11013504610160 CAPSULE in 1 BOTTLE (0135-0461-01)
- ndc110135046105120 CAPSULE in 1 BOTTLE (0135-0461-05)
- ndc110135046106170 CAPSULE in 1 BOTTLE (0135-0461-06)
Annotations
UNII (FDA Substance ID)
95M8R751W8
ORLISTAT
RxCUI 37925
Orange Book
N021887
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": {
"a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f": {
"match": "brand_token",
"title": "ALLI (ORLISTAT) CAPSULE [HALEON US HOLDINGS LLC]",
"spl_version": "15",
"published_date": "2026-03-20"
}
},
"productid": "0135-0461_4d51b8f1-a819-7ff6-e063-6294a90a82bc",
"productndc": "0135-0461",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "021887",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "60MG",
"product_no": "001",
"approval_date": "Feb 7, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ORLISTAT",
"proprietary_name": "ALLI",
"active_ingred_unit": "mg/1",
"application_number": "NDA021887",
"marketing_category": "NDA",
"nonproprietary_name": "orlistat",
"start_marketing_date": "20070207",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code A08AB01.
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