alli

Generic: orlistat

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name alli
Generic Name orlistat
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

orlistat 60 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-805
Product ID 71610-805_14a73146-26ef-3d96-e063-6394a90ab4ce
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 71610805
Hyphenated Format 71610-805

Supplemental Identifiers

RxCUI
692876 723846
UNII
95M8R751W8
NUI
N0000175591 N0000009916

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
  • 2280 CAPSULE in 1 BOTTLE (71610-805-34)
source: ndc

Packages (1)

71610-805-34 2280 CAPSULE in 1 BOTTLE (71610-805-34)

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": "14a73146-26ef-3d96-e063-6394a90ab4ce", "openfda": {"nui": ["N0000175591", "N0000009916"], "unii": ["95M8R751W8"], "rxcui": ["692876", "723846"], "spl_set_id": ["14a75092-f910-53df-e063-6294a90acc66"], "pharm_class_epc": ["Intestinal Lipase Inhibitor [EPC]"], "pharm_class_moa": ["Lipase Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "2280 CAPSULE in 1 BOTTLE (71610-805-34)", "package_ndc": "71610-805-34", "marketing_start_date": "20240322"}], "brand_name": "ALLI", "product_id": "71610-805_14a73146-26ef-3d96-e063-6394a90ab4ce", "dosage_form": "CAPSULE", "pharm_class": ["Intestinal Lipase Inhibitor [EPC]", "Lipase Inhibitors [MoA]"], "product_ndc": "71610-805", "generic_name": "orlistat", "labeler_name": "Aphena Pharma Solutions - Tennessee, 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"}