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United States · US · US:71610-805_14a73146-26ef-3d96-e063-6394a90ab4ce

ALLI

Orange BookUNIISPLATC A08AB01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeA08AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7161080534
    2280 CAPSULE in 1 BOTTLE (71610-805-34)

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": "71610-805_14a73146-26ef-3d96-e063-6394a90ab4ce",
  "productndc": "71610-805",
  "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"
}

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