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 useInitial U.S. Approval: 1998

Approved
Approval ID

07e49b4e-5a6d-66aa-97c8-7ca582d44771

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 31, 2019

Manufacturers
FDA

Dr. Reddy's Laboratories, Inc.

DUNS: 802315887

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 Code43598-564
Application NumberANDA204910
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paricalcitol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2019
FDA Product Classification

INGREDIENTS (4)

PARICALCITOLActive
Quantity: 5 ug in 1 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 Code43598-565
Application NumberANDA204910
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paricalcitol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2019
FDA Product Classification

INGREDIENTS (4)

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

Paricalcitol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43598-562
Application NumberANDA204910
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paricalcitol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2019
FDA Product Classification

INGREDIENTS (4)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PARICALCITOLActive
Quantity: 5 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 Code43598-563
Application NumberANDA204910
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paricalcitol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2019
FDA Product Classification

INGREDIENTS (4)

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