NDC 61269-460

Xenical

Orlistat

Xenical is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by H2-pharma Llc. The primary component is Orlistat.

• Product ID: 61269-460_5a15ec2a-80d5-46c5-8eee-583e081d10c8
• NDC: 61269-460
• 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 Category: NDA / NDA
• Application Number: NDA020766
• Labeler Name: H2-Pharma LLC
• Substance Name: ORLISTAT
• Active Ingredient Strength: 120 mg/1
• Pharm Classes: Intestinal Lipase Inhibitor [EPC],Lipase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 61269-460-90

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

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

NDC SPL Data Element Entries

NDC 61269-460-90 [61269046090]

Xenical CAPSULE

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

Drug Details

Active Ingredients

Ingredient	Strength
ORLISTAT	120 mg/1

OpenFDA Data

• SPL SET ID: 6240792b-9224-2d10-e053-2a91aa0a2c3e
• Manufacturer:
  • H2-Pharma LLC
• UNII:
  • 95M8R751W8
• RxNorm Concept Unique ID - RxCUI:
  • 314153
  • 226917

Pharmacological Class

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

Medicade Reported Pricing

61269046090 XENICAL 120 MG CAPSULE

Pricing Unit: EA | Drug Type:

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