NDC 69516-010

Ocaliva

Obeticholic Acid

Ocaliva is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Intercept Pharmaceuticals Inc. The primary component is Obeticholic Acid.

Product ID69516-010_1d6c9e9d-e17d-4609-91fa-75e5bdbc5114
NDC69516-010
Product TypeHuman Prescription Drug
Proprietary NameOcaliva
Generic NameObeticholic Acid
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-05-27
Marketing CategoryNDA / NDA
Application NumberNDA207999
Labeler NameIntercept Pharmaceuticals Inc
Substance NameOBETICHOLIC ACID
Active Ingredient Strength10 mg/1
Pharm ClassesFarnesoid X Receptor Agonist [EPC], Farnesoid X Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69516-010-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-010-30)
Marketing Start Date2016-05-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69516-010-30 [69516001030]

Ocaliva TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207999
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-27

Drug Details

Active Ingredients

IngredientStrength
OBETICHOLIC ACID10 mg/1

OpenFDA Data

SPL SET ID:cdfbe0cd-eb15-45a1-ac17-531bcda21aec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1798370
  • 1798373
  • 1798375
  • 1798364
  • Pharmacological Class

    • Farnesoid X Receptor Agonist [EPC]
    • Farnesoid X Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Ocaliva" or generic name "Obeticholic Acid"

    NDCBrand NameGeneric Name
    69516-005OcalivaObeticholic Acid
    69516-010OcalivaObeticholic Acid

    Trademark Results [Ocaliva]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OCALIVA
    OCALIVA
    86710924 5033038 Live/Registered
    INTERCEPT PHARMACEUTICALS, INC.
    2015-07-31
    OCALIVA
    OCALIVA
    86710865 5014396 Live/Registered
    INTERCEPT PHARMACEUTICALS, INC.
    2015-07-31

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