Ocaliva (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 5 mg Tablet Bottle Label

NDC 69516-005-30
Rx only

OCALIVA®
(obeticholic acid) tablets

5 mg

30 tabletsIntercept

PRINCIPAL DISPLAY PANEL -- 5 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Bottle Label

NDC 69516-010-30
Rx only

OCALIVA®
(obeticholic acid) tablets

10 mg

30 tabletsIntercept

PRINCIPAL DISPLAY PANEL -- 10 mg Tablet Bottle Label
(click image for full-size original)
OCALIVA obeticholic acid tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69516-005
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OBETICHOLIC ACID (OBETICHOLIC ACID) OBETICHOLIC ACID 5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 8mm
Flavor Imprint Code INT;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69516-005-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207999 05/27/2016
OCALIVA obeticholic acid tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69516-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OBETICHOLIC ACID (OBETICHOLIC ACID) OBETICHOLIC ACID 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape TRIANGLE Size 8mm
Flavor Imprint Code INT;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69516-010-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207999 05/27/2016
Labeler — Intercept Pharmaceuticals Inc (966658416)
Establishment
Name Address ID/FEI Operations
Pharmacia & Upjohn Company LLC 618054084 ANALYSIS (69516-005), ANALYSIS (69516-010), API MANUFACTURE (69516-005), API MANUFACTURE (69516-010)

Revised: 10/2022 Intercept Pharmaceuticals Inc

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