PARICALCITOL

PARICALCITOL- paricalcitol capsule, liquid filled
TIME CAP LABORATORIES, INC

HOW SUPPLIED

4 mcg, light yellow color oval shaped soft gelatin capsules imprinted with 17 in black ink in bottles of 30

HOW SUPPLIED

2 mcg, brown clolor, oval shaped soft gelatin capsule imprinted 12 in black ink, in bottles of 30

HOW SUPPLIED

1 mcg, gray color oval shaped soft gelatin capsule imprinted 12 in black ink, in bottles of 30

PDP 4 MCG

4 MCG LABEL
(click image for full-size original)

2 mcg label

2 mcg
(click image for full-size original)

PDP 1 MCG

I MCG LABEL
(click image for full-size original)

PARICALCITOL
paricalcitol capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-689
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 4 ug
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
ALCOHOL
BUTYLATED HYDROXYTOLUENE
GELATIN
GLYCERIN
SORBITOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
WATER
PROPYLENE GLYCOL
BUTYL ALCOHOL
SHELLAC
AMMONIA
Product Characteristics
Color white ((LIGHT YELLOW)) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-689-03 30 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204948 01/03/2017
PARICALCITOL
paricalcitol capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-688
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 2 ug
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
ALCOHOL
BUTYLATED HYDROXYTOLUENE
GELATIN
SORBITOL
FERRIC OXIDE RED
WATER
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
PROPYLENE GLYCOL
BUTYL ALCOHOL
SHELLAC
AMMONIA
Product Characteristics
Color brown Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-688-03 30 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204948 12/30/2015
PARICALCITOL
paricalcitol capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-687
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 1 ug
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
ALCOHOL
BUTYLATED HYDROXYTOLUENE
GELATIN
GLYCERIN
SORBITOL
TITANIUM DIOXIDE
WATER
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
SHELLAC
AMMONIA
Product Characteristics
Color gray Score no score
Shape OVAL Size 9mm
Flavor Imprint Code 12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-687-03 30 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204948 01/03/2017
Labeler — TIME CAP LABORATORIES, INC (037052099)
Registrant — TIME CAP LABORATORIES, INC (037052099)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LIMITED 925822975 manufacture (49483-689), manufacture (49483-688), manufacture (49483-687)

Revised: 09/2019 TIME CAP LABORATORIES, INC

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