NDC 69516-005

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 ID: 69516-005_1d6c9e9d-e17d-4609-91fa-75e5bdbc5114
• NDC: 69516-005
• Product Type: Human Prescription Drug
• Proprietary Name: Ocaliva
• Generic Name: Obeticholic Acid
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-05-27
• Marketing Category: NDA / NDA
• Application Number: NDA207999
• Labeler Name: Intercept Pharmaceuticals Inc
• Substance Name: OBETICHOLIC ACID
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Farnesoid X Receptor Agonist [EPC], Farnesoid X Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 69516-005-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-005-30)

• Marketing Start Date: 2016-05-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69516-005-30 [69516000530]

Ocaliva TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207999
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-05-27

Drug Details

Active Ingredients

Ingredient	Strength
OBETICHOLIC ACID	5 mg/1

OpenFDA Data

• SPL SET ID: cdfbe0cd-eb15-45a1-ac17-531bcda21aec
• Manufacturer:
  • Intercept Pharmaceuticals Inc
• UNII:
  • 0462Z4S4OZ
• 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"

NDC	Brand Name	Generic Name
69516-005	Ocaliva	Obeticholic Acid
69516-010	Ocaliva	Obeticholic Acid