paricalcitol

Generic: paricalcitol

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name paricalcitol
Generic Name paricalcitol
Labeler accord healthcare, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

paricalcitol 5 ug/mL

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-311
Product ID 16729-311_1e7e9c4e-79dd-a776-e063-6394a90a43a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207174
Listing Expiration 2026-12-31
Marketing Start 2016-03-24

Pharmacologic Class

Established (EPC)
vitamin d2 analog [epc] vitamin d analog [epc]
Chemical Structure
ergocalciferols [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729311
Hyphenated Format 16729-311

Supplemental Identifiers

RxCUI
200321 1736919 1736931
UPC
0316729310635 0316729311304 0316729311632 0316729311083
UNII
6702D36OG5
NUI
M0007651 N0000175907 N0000175849

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name paricalcitol (source: ndc)
Generic Name paricalcitol (source: ndc)
Application Number NDA207174 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 ug/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (16729-311-08) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (16729-311-30) / 2 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-311-63) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 25 VIAL, MULTI-DOSE in 1 CARTON (16729-311-93) / 2 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (4)

16729-311-08 25 VIAL, SINGLE-DOSE in 1 CARTON (16729-311-08) / 1 mL in 1 VIAL, SINGLE-DOSE 16729-311-30 1 VIAL, MULTI-DOSE in 1 CARTON (16729-311-30) / 2 mL in 1 VIAL, MULTI-DOSE 16729-311-63 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-311-63) / 1 mL in 1 VIAL, SINGLE-DOSE 16729-311-93 25 VIAL, MULTI-DOSE in 1 CARTON (16729-311-93) / 2 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

paricalcitol (5 ug/mL)

Linked Drug Pages (1)

Paricalcitol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1e7e9c4e-79dd-a776-e063-6394a90a43a1", "openfda": {"nui": ["M0007651", "N0000175907", "N0000175849"], "upc": ["0316729310635", "0316729311304", "0316729311632", "0316729311083"], "unii": ["6702D36OG5"], "rxcui": ["200321", "1736919", "1736931"], "spl_set_id": ["2b7c7587-2042-0d9c-e054-00144ff88e88"], "pharm_class_cs": ["Ergocalciferols [CS]"], "pharm_class_epc": ["Vitamin D2 Analog [EPC]", "Vitamin D Analog [EPC]"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (16729-311-08)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "16729-311-08", "marketing_start_date": "20160324"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-311-30)  / 2 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-311-30", "marketing_start_date": "20160324"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (16729-311-63)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "16729-311-63", "marketing_start_date": "20160324"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (16729-311-93)  / 2 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-311-93", "marketing_start_date": "20160324"}], "brand_name": "Paricalcitol", "product_id": "16729-311_1e7e9c4e-79dd-a776-e063-6394a90a43a1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Ergocalciferols [CS]", "Vitamin D Analog [EPC]", "Vitamin D2 Analog [EPC]"], "product_ndc": "16729-311", "generic_name": "Paricalcitol", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paricalcitol", "active_ingredients": [{"name": "PARICALCITOL", "strength": "5 ug/mL"}], "application_number": "NDA207174", "marketing_category": "NDA", "marketing_start_date": "20160324", "listing_expiration_date": "20261231"}