xenical

Generic: orlistat

Labeler: h2-pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xenical
Generic Name orlistat
Labeler h2-pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

orlistat 120 mg/1

Manufacturer
H2-Pharma LLC

Identifiers & Regulatory

Product NDC 61269-460
Product ID 61269-460_4fd710c5-6147-498a-ade9-0cce6e1513c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020766
Listing Expiration 2027-12-31
Marketing Start 2010-12-17

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 61269460
Hyphenated Format 61269-460

Supplemental Identifiers

RxCUI
226917 314153
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 xenical (source: ndc)
Generic Name orlistat (source: ndc)
Application Number NDA020766 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-460-90)
source: ndc

Packages (1)

61269-460-90 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-460-90)

Ingredients (1)

orlistat (120 mg/1)

Linked Drug Pages (1)

Xenical ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4fd710c5-6147-498a-ade9-0cce6e1513c7", "openfda": {"nui": ["N0000175591", "N0000009916"], "unii": ["95M8R751W8"], "rxcui": ["226917", "314153"], "spl_set_id": ["6240792b-9224-2d10-e053-2a91aa0a2c3e"], "pharm_class_epc": ["Intestinal Lipase Inhibitor [EPC]"], "pharm_class_moa": ["Lipase Inhibitors [MoA]"], "manufacturer_name": ["H2-Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (61269-460-90)", "package_ndc": "61269-460-90", "marketing_start_date": "20101217"}], "brand_name": "Xenical", "product_id": "61269-460_4fd710c5-6147-498a-ade9-0cce6e1513c7", "dosage_form": "CAPSULE", "pharm_class": ["Intestinal Lipase Inhibitor [EPC]", "Lipase Inhibitors [MoA]"], "product_ndc": "61269-460", "generic_name": "orlistat", "labeler_name": "H2-Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xenical", "active_ingredients": [{"name": "ORLISTAT", "strength": "120 mg/1"}], "application_number": "NDA020766", "marketing_category": "NDA", "marketing_start_date": "20101217", "listing_expiration_date": "20271231"}