X

Manufacturer: AX Pharmaceutical Corp
Effective date: 2017-08-19
Label type: BULK INGREDIENT
Version: 4
Source: full-release
Hydrated at: 2026-06-01 02:48:33

Label at a glance#

ProductX

Active ingredientORLISTAT

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3f93084-d1af-0d2d-125b-736522e0a7a2	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62157-394-01	X	500 g in 1 VIAL	POWDER	500		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62157-394	X (ORLISTAT) POWDER [AX PHARMACEUTICAL CORP]	4	1 package rows	20170820_cc343deb-9d54-4a00-9a3c-6632d4af250c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

X
ORLISTAT
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62157-394	62157-394-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ORLISTAT	95M8R751W8	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLI	ORLISTAT	Haleon US Holdings LLC	a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f	2026-03-18	Warnings	Name fallback generic name: ORLISTAT
ORLISTAT	ORLISTAT	H2-Pharma LLC	f81dfaeb-46d5-47ce-9ef6-19259f5ac61c	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: ORLISTAT
Xenical	ORLISTAT	H2-Pharma LLC	6240792b-9224-2d10-e053-2a91aa0a2c3e	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: ORLISTAT
ALLI	ORLISTAT	Aphena Pharma Solutions - Tennessee, LLC	14a75092-f910-53df-e063-6294a90acc66	2024-03-27	Warnings	Name fallback generic name: ORLISTAT

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.