Quick answers
- What is Paricalcitol used for?
- The FDA-approved label (Zemplar, AbbVie Inc., August 7, 2024) says: “ZEMPLAR is a vitamin D analog indicated in adults and pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with: Chronic kidney disease (CKD) Stages 3 and 4. CKD Stage 5 in patients on hemodialysis or peritoneal dialysis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Paricalcitol have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Paricalcitol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Paricalcitol been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started March 24, 2016 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Paricalcitol?
- 11 companies list prescription products of Paricalcitol in the FDA NDC Directory, including Amneal Pharmaceuticals LLC, AbbVie Inc. and Bryant Ranch Prepack.
What Paricalcitol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZEMPLAR is a vitamin D analog indicated in adults and pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with: Chronic kidney disease (CKD) Stages 3 and 4. CKD Stage 5 in patients on hemodialysis or peritoneal dialysis. …
— FDA label: Zemplar, AbbVie Inc., effective August 7, 2024. Read the full label on DailyMed →
The FDA has 16 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, liquid filled · Injection · Capsule · Injection, solution |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 39 in the FDA NDC Directory |
| Brand names | Zemplar |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| paricalcitol 1 ug capsule | Generic | $1.24 per capsule |
| paricalcitol 1 ug capsule, liquid filled | Generic | $1.24 per capsule |
| paricalcitol 2 ug capsule | Generic | $2.52 per capsule |
| paricalcitol 2 ug capsule, liquid filled | Generic | $2.52 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals LLC7 products
- AbbVie Inc.4 products
- Bryant Ranch Prepack4 products
- Eugia US LLC4 products
- Time Cap Laboratories, Inc3 products
- Aurobindo Pharma Limited3 products
- Bionpharma Inc.3 products
- Marksans Pharma Limited3 products
- Dr. Reddy's Laboratories Limited3 products
- West-Ward Pharmaceuticals Corp3 products
- Accord Healthcare Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020819 ZEMPLAR | Abbvie | April 17, 1998 | 20, latest October 20, 2022 2022: Labeling · 2021: Manufacturing (CMC) · 2021: Labeling |
| NDA021606 ZEMPLAR | Abbvie | May 26, 2005 | 12, latest October 18, 2016 2016: Efficacy · 2016: Efficacy · 2015: Manufacturing (CMC) |
| NDA205917 PARICALCITOL | Hikma Pharms | November 18, 2014 | 1, latest June 17, 2026 2026: Labeling |
| NDA207174 PARICALCITOL | Accord Hlthcare | February 4, 2016 | 1, latest October 17, 2019 2019: Labeling |
Generic approvals (7)
- ANDA202539Bionpharma · March 27, 2014
- ANDA091412Chartwell Rx · June 24, 2014
- ANDA204327Amneal Pharms · January 13, 2016
- ANDA207672Aurobindo Pharma Ltd · January 14, 2016
- ANDA204948Pharmazone · October 7, 2016
- ANDA206699Amneal Pharms Co · March 9, 2017
- ANDA205982Eugia Pharma · October 9, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 24, 2016 · Class III · Terminated · D-0833-2016
Failed Content Uniformity Specifications
Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30. — AbbVie Inc.
-
November 4, 2015 · Class III · Terminated · D-0719-2016
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30 — Dr. Reddy's Laboratories, Inc.
-
November 4, 2015 · Class III · Terminated · D-0720-2016
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30 — Dr. Reddy's Laboratories, Inc.
-
November 4, 2015 · Class III · Terminated · D-0721-2016
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30 — Dr. Reddy's Laboratories, Inc.
-
May 14, 2012 · Class II · Terminated · D-1388-2012
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05 — Abbott Laboratories
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zemplar, AbbVie Inc., effective August 7, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →