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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

  • ndc11
    0135046101
    60 CAPSULE in 1 BOTTLE (0135-0461-01)
  • ndc11
    0135046105
    120 CAPSULE in 1 BOTTLE (0135-0461-05)
  • ndc11
    0135046106
    170 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

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