MedPath

PARICALCITOL

These highlights do not include all the information needed to use PARICALCITOL INJECTION safely and effectively. See full prescribing information for PARICALCITOL INJECTION. Paricalcitol injection, for intravenous use Initial U.S. Approval: 1998

Approved
Approval ID

6937c596-9ca4-480e-9090-b9d8a3c271c8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 8, 2023

Manufacturers
FDA

Eugia US LLC

DUNS: 968961354

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

PARICALCITOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-214
Application NumberANDA205982
Product Classification
M
Marketing Category
C73584
G
Generic Name
PARICALCITOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 9, 2023
FDA Product Classification

INGREDIENTS (4)

PARICALCITOLActive
Quantity: 10 ug in 2 mL
Code: 6702D36OG5
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

PARICALCITOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-215
Application NumberANDA205982
Product Classification
M
Marketing Category
C73584
G
Generic Name
PARICALCITOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 9, 2023
FDA Product Classification

INGREDIENTS (4)

PARICALCITOLActive
Quantity: 10 ug in 2 mL
Code: 6702D36OG5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

PARICALCITOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-212
Application NumberANDA205982
Product Classification
M
Marketing Category
C73584
G
Generic Name
PARICALCITOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 9, 2023
FDA Product Classification

INGREDIENTS (4)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PARICALCITOLActive
Quantity: 2 ug in 1 mL
Code: 6702D36OG5
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

PARICALCITOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-213
Application NumberANDA205982
Product Classification
M
Marketing Category
C73584
G
Generic Name
PARICALCITOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 9, 2023
FDA Product Classification

INGREDIENTS (4)

PARICALCITOLActive
Quantity: 5 ug in 1 mL
Code: 6702D36OG5
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

PARICALCITOL - FDA Drug Approval Details