NDC 0004-0257

Xenical

Orlistat

Xenical is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Orlistat.

• Product ID: 0004-0257_0fc18072-af1c-4f70-bd22-c168a43d5262
• NDC: 0004-0257
• Product Type: Human Prescription Drug
• Proprietary Name: Xenical
• Generic Name: Orlistat
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2010-12-17
• Marketing End Date: 2020-02-29
• Marketing Category: NDA / NDA
• Application Number: NDA020766
• Labeler Name: Genentech, Inc.
• Substance Name: ORLISTAT
• Active Ingredient Strength: 120 mg/1
• Pharm Classes: Intestinal Lipase Inhibitor [EPC],Lipase Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0004-0257-52

90 CAPSULE in 1 BOTTLE, PLASTIC (0004-0257-52)

• Marketing Start Date: 2010-12-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0004-0257-52 [00004025752]

Xenical CAPSULE

• Marketing Category: NDA
• Application Number: NDA020766
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-12-17
• Marketing End Date: 2020-02-29

Drug Details

Active Ingredients

Ingredient	Strength
ORLISTAT	120 mg/1

OpenFDA Data

• SPL SET ID: 5bbdc95b-82a1-4ba5-8185-6504ff68cc06
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • 95M8R751W8
• RxNorm Concept Unique ID - RxCUI:
  • 314153
  • 226917

Pharmacological Class

• Intestinal Lipase Inhibitor [EPC]
• Lipase Inhibitors [MoA]

NDC Crossover Matching brand name "Xenical" or generic name "Orlistat"

NDC	Brand Name	Generic Name
0004-0257	Xenical	orlistat
61269-460	Xenical	orlistat
0135-0461	ALLI	orlistat
61269-565	ORLISTAT	orlistat