NDC 61168-101

KYBELLA

Deoxycholic Acid

KYBELLA is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Kythera Biopharmaceuticals Inc.. The primary component is Deoxycholic Acid.

Product ID61168-101_6af06e47-b62a-4521-90a9-e473476c26a9
NDC61168-101
Product TypeHuman Prescription Drug
Proprietary NameKYBELLA
Generic NameDeoxycholic Acid
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2015-06-08
Marketing CategoryNDA / NDA
Application NumberNDA206333
Labeler NameKythera Biopharmaceuticals Inc.
Substance NameDEOXYCHOLIC ACID
Active Ingredient Strength20 mg/2mL
Pharm ClassesCytolytic Agent [EPC],Decreased Cell Membrane Integrity [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 61168-101-03

2 VIAL, GLASS in 1 CARTON (61168-101-03) > 2 mL in 1 VIAL, GLASS
Marketing Start Date2018-08-01
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 61168-101-01 [61168010101]

KYBELLA INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA206333
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-06-08

NDC 61168-101-94 [61168010194]

KYBELLA INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA206333
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-08

NDC 61168-101-04 [61168010104]

KYBELLA INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA206333
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-06-08

NDC 61168-101-91 [61168010191]

KYBELLA INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA206333
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-08

Drug Details

Active Ingredients

IngredientStrength
DEOXYCHOLIC ACID20 mg/2mL

OpenFDA Data

SPL SET ID:fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1649980
  • 1649975
  • Pharmacological Class

    • Cytolytic Agent [EPC]
    • Decreased Cell Membrane Integrity [PE]
    • Cytolytic Agent [EPC]
    • Decreased Cell Membrane Integrity [PE]

    Trademark Results [KYBELLA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KYBELLA
    KYBELLA
    86128553 4795973 Live/Registered
    ALLERGAN SALES, LLC
    2013-11-25

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