PARICALCITOL capsule, liquid filled

Paricalcitol by

Drug Labeling and Warnings

Paricalcitol by is a Prescription medication manufactured, distributed, or labeled by TIME CAP LABORATORIES, INC, MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

2 mcg label

PDP 1 MCG

INGREDIENTS AND APPEARANCE

PARICALCITOL 
paricalcitol capsule, liquid filled

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49483-689
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PARICALCITOL (UNII: 6702D36OG5) (PARICALCITOL - UNII:6702D36OG5)	PARICALCITOL	4 ug

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
SHELLAC (UNII: 46N107B71O)
AMMONIA (UNII: 5138Q19F1X)

Product Characteristics
Color	white ((LIGHT YELLOW))	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-689-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2017

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PARICALCITOL (UNII: 6702D36OG5) (PARICALCITOL - UNII:6702D36OG5)	PARICALCITOL	2 ug

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GELATIN (UNII: 2G86QN327L)
SORBITOL (UNII: 506T60A25R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
SHELLAC (UNII: 46N107B71O)
AMMONIA (UNII: 5138Q19F1X)

Product Characteristics
Color	brown	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	14
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-688-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2017

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PARICALCITOL (UNII: 6702D36OG5) (PARICALCITOL - UNII:6702D36OG5)	PARICALCITOL	1 ug

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
SHELLAC (UNII: 46N107B71O)
AMMONIA (UNII: 5138Q19F1X)

Product Characteristics
Color	gray	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-687-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2017

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	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(49483-689, 49483-688, 49483-687)