alli

Generic: orlistat

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name alli
Generic Name orlistat
Labeler haleon us holdings llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

orlistat 60 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0461
Product ID 0135-0461_0f157213-26c7-9865-e063-6394a90a84ca
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021887
Listing Expiration 2026-12-31
Marketing Start 2007-02-07

Pharmacologic Class

Established (EPC)
intestinal lipase inhibitor [epc]
Mechanism of Action
lipase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350461
Hyphenated Format 0135-0461

Supplemental Identifiers

RxCUI
692876 723846
UNII
95M8R751W8
NUI
N0000175591 N0000009916

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name alli (source: ndc)
Generic Name orlistat (source: ndc)
Application Number NDA021887 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (0135-0461-01)
  • 90 CAPSULE in 1 BOTTLE (0135-0461-02)
  • 120 CAPSULE in 1 BOTTLE (0135-0461-03)
  • 120 CAPSULE in 1 BOTTLE (0135-0461-05)
  • 170 CAPSULE in 1 BOTTLE (0135-0461-06)
  • 21 CAPSULE in 1 BOTTLE (0135-0461-07)
  • 2 BOTTLE in 1 CARTON (0135-0461-08) / 60 CAPSULE in 1 BOTTLE
source: ndc

Packages (7)

0135-0461-01 60 CAPSULE in 1 BOTTLE (0135-0461-01) 0135-0461-02 90 CAPSULE in 1 BOTTLE (0135-0461-02) 0135-0461-03 120 CAPSULE in 1 BOTTLE (0135-0461-03) 0135-0461-05 120 CAPSULE in 1 BOTTLE (0135-0461-05) 0135-0461-06 170 CAPSULE in 1 BOTTLE (0135-0461-06) 0135-0461-07 21 CAPSULE in 1 BOTTLE (0135-0461-07) 0135-0461-08 2 BOTTLE in 1 CARTON (0135-0461-08) / 60 CAPSULE in 1 BOTTLE

Ingredients (1)

orlistat (60 mg/1)

Linked Drug Pages (1)

ALLI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0f157213-26c7-9865-e063-6394a90a84ca", "openfda": {"nui": ["N0000175591", "N0000009916"], "unii": ["95M8R751W8"], "rxcui": ["692876", "723846"], "spl_set_id": ["a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f"], "pharm_class_epc": ["Intestinal Lipase Inhibitor [EPC]"], "pharm_class_moa": ["Lipase Inhibitors [MoA]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (0135-0461-01)", "package_ndc": "0135-0461-01", "marketing_start_date": "20160901"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (0135-0461-02)", "package_ndc": "0135-0461-02", "marketing_start_date": "20070207"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (0135-0461-03)", "package_ndc": "0135-0461-03", "marketing_start_date": "20070207"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (0135-0461-05)", "package_ndc": "0135-0461-05", "marketing_start_date": "20070207"}, {"sample": false, "description": "170 CAPSULE in 1 BOTTLE (0135-0461-06)", "package_ndc": "0135-0461-06", "marketing_start_date": "20070207"}, {"sample": false, "description": "21 CAPSULE in 1 BOTTLE (0135-0461-07)", "package_ndc": "0135-0461-07", "marketing_start_date": "20070207"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (0135-0461-08)  / 60 CAPSULE in 1 BOTTLE", "package_ndc": "0135-0461-08", "marketing_start_date": "20070207"}], "brand_name": "ALLI", "product_id": "0135-0461_0f157213-26c7-9865-e063-6394a90a84ca", "dosage_form": "CAPSULE", "pharm_class": ["Intestinal Lipase Inhibitor [EPC]", "Lipase Inhibitors [MoA]"], "product_ndc": "0135-0461", "generic_name": "orlistat", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ALLI", "active_ingredients": [{"name": "ORLISTAT", "strength": "60 mg/1"}], "application_number": "NDA021887", "marketing_category": "NDA", "marketing_start_date": "20070207", "listing_expiration_date": "20261231"}