Paricalcitol (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

NDC 0143-9625-01 Rx only
Paricalcitol
Injection
2 mcg/mL
Discard unused portion
1 mL Single Dose VialFor Intravenous Use Only

NDC 0143-9625-01 Rx only Paricalcitol Injection 2 mcg/mL Discard unused portion 1 mL Single Dose Vial For Intravenous Use Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-9624-01 Rx only
Paricalcitol
Injection
5 mcg/mL
Discard unused portion

1 mL Single Dose VialFor Intravenous Use Only

NDC 0143-9624-01 Rx only Paricalcitol Injection 5 mcg/mL Discard unused portion 1 mL Single Dose Vial For Intravenous Use Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-9596-01 Rx only
Paricalcitol
Injection
10 mcg/2 mL
(5 mcg/mL)
2 mL Multiple Dose VialFor Intravenous Use Only

NDC 0143-9596-01 Rx only Paricalcitol Injection 10 mcg/2 mL (5 mcg/mL) 2 mL Multiple Dose Vial For Intravenous Use Only
(click image for full-size original)
PARICALCITOL paricalcitol injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9625
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 2 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
SORBITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9625-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0143-9625-01)
1 NDC:0143-9625-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0143-9625-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205917 11/18/2014
PARICALCITOL paricalcitol injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9624
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 5 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
SORBITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9624-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0143-9624-01)
1 NDC:0143-9624-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0143-9624-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205917 11/18/2014
PARICALCITOL paricalcitol injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9596
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 5 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
SORBITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9596-25 25 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (0143-9596-01)
1 NDC:0143-9596-01 2 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0143-9596-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205917 11/18/2014
Labeler — West-Ward Pharmaceutical Corp (001230762)
Establishment
Name Address ID/FEI Operations
Exela Pharma Sciences, LLC 831274399 MANUFACTURE (0143-9596), MANUFACTURE (0143-9625), MANUFACTURE (0143-9624)

Revised: 06/2015 West-Ward Pharmaceutical Corp

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