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 ID0004-0257_0fc18072-af1c-4f70-bd22-c168a43d5262
NDC0004-0257
Product TypeHuman Prescription Drug
Proprietary NameXenical
Generic NameOrlistat
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-12-17
Marketing End Date2020-02-29
Marketing CategoryNDA / NDA
Application NumberNDA020766
Labeler NameGenentech, Inc.
Substance NameORLISTAT
Active Ingredient Strength120 mg/1
Pharm ClassesIntestinal Lipase Inhibitor [EPC],Lipase Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 0004-0257-52

90 CAPSULE in 1 BOTTLE, PLASTIC (0004-0257-52)
Marketing Start Date2010-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0004-0257-52 [00004025752]

Xenical CAPSULE
Marketing CategoryNDA
Application NumberNDA020766
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-17
Marketing End Date2020-02-29

Drug Details

Active Ingredients

IngredientStrength
ORLISTAT120 mg/1

OpenFDA Data

SPL SET ID:5bbdc95b-82a1-4ba5-8185-6504ff68cc06
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0004-0257Xenicalorlistat
    61269-460Xenicalorlistat
    0135-0461ALLIorlistat
    61269-565ORLISTATorlistat

    Trademark Results [Xenical]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XENICAL
    XENICAL
    74419821 1906281 Live/Registered
    CHEPLAPHARM ARZNEIMITTEL GMBH
    1993-08-02

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