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Paricalcitol 2 ug/mL Injection, 25 vials — NDC 00143-9625-25 package photo
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Paricalcitol 2 ug/mL Injection, 25 vials — NDC 0143-9625-25 (Billing 00143-9625-25)

by West-Ward Pharmaceuticals Corp · 25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 25 vials of Paricalcitol 2 ug/mL Injection from West-Ward Pharmaceuticals Corp, marketed since Nov 2014 and currently FDA-listed. It is this product's only package size.

NDC 00143-9625-25
🏷️ FDA NDC (as labeled) 0143-9625-25 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0143-9625-25 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0143 labeler · 9625 product · 25 package
Package marketed since
Nov 18, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0143962525 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0143-9625-25
Product NDC 0143-9625
11-digit billing NDC 00143962525
NCPDP billing unit ML — per mL (volume)
RxCUI 200321, 1736919, 1736931
UNII 6702D36OG5
Application # NDA205917
SPL Set ID 4db985c4-3ba2-4967-898b-35af77f150de
Established class (EPC) Vitamin D2 Analog; Vitamin D Analog
Chemical class Ergocalciferols
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-11-18
Route INTRAVENOUS
Dosage form INJECTION
Substance PARICALCITOL

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 30905070002010
GPI class Paricalcitol
GCN Seq No 073092
GCN 37416
HICL code 018250
Ingredient (HICL) Paricalcitol
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P4
Therapeutic class — intermediate (HIC2) Parathyroid/Bone Resorption Drugs
HIC3 code P4D
Therapeutic class — specific (HIC3) Hyperparathyroid Tx Agents - Vitamin D Analog-Type
AHFS code 88:16.00.00
AHFS class Vitamin D
FDB label name PARICALCITOL 2 MCG/ML VIAL
FDB brand name Paricalcitol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 073092
  • GCN: 37416
  • GPI-14 (Medi-Span): 30905070002010
  • HICL (First Databank): 018250
  • AHFS class code: 88:16.00.00
  • RxCUI (RxNorm): 200321
Why two NDCs? The FDA registers this code as 0143-9625-25 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00143-9625-25. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Vitamin D Analog class.

Pharmacologic class Vitamin D Analog, Vitamin D2 Analog
Drug family (ATC) Other anti-parathyroid agents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PARICALCITOL 2 MCG/ML VIAL Ingredient Paricalcitol
📗 Our plain-language guide HelloPharmacist
  • It treats and prevents secondary hyperparathyroidism, which is high PTH caused by chronic kidney disease. It works like vitamin D to bring PTH down. Capsules and injection are used...
  • Capsules are swallowed, either daily or three times a week depending on your plan. You can take them with or without food. The injection is given during dialysis through your acces...
  • Diarrhea, nausea, vomiting, dizziness, high blood pressure and swelling are among the most common. Mention anything that bothers you or does not go away.
  • Watch for tiredness, trouble thinking clearly, poor appetite, nausea, vomiting, constipation, increased thirst or urination, and weight loss. Call your doctor if these appear or wo...
📖 Read our full Paricalcitol guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2501 $0.899 / J2501 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0143-9625-25
11-digit billing NDC00143-9625-25
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2501
DescriptorINJECTION, PARICALCITOL, 1 MCG
Billing units / pkg2 units
How the units are derivedThis package is 1 ML; the HCPCS unit is 1 MCG, so one package = 2 billing units.
Medicare Part B spend (2025 (Q1-Q4))$545 · 11 claims · $49.55 per claim (all NDCs under J2501)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00143-9625-25 You're viewing this Main listing 25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE 2014-11-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zemplar 2 ug/mL 00074-4637-01 AbbVie 25 vials — AP FDA listed —
Paricalcitol 2 ug/mLthis 00143-9625-25 West-Ward 25 vials — — FDA listed —
Paricalcitol 2 ug/mL 16729-0310-08 Accord 25 vials — AP FDA listed —
Paricalcitol 2 ug/mL 55150-0212-01 Eugia 25 vials — — FDA listed —
Paricalcitol 2 ug/mL 70121-1033-05 Amneal 25 vials — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2014
On the market since
Nov 2014
📍
2026
Currently FDA-listed
12 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Paricalcitol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerWest-Ward Pharmaceuticals Corp
Application holderHIKMA PHARMACEUTICALS CO LTD
FDA applicationNDA205917 (NDA)
Labeler code00143
First marketedNov 2014
Product typeHuman Prescription Drug
Portfolio10 products on file

More NDCs from West-Ward Pharmaceuticals Corp labeler code 00143

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 58 words ▾

1 INDICATIONS AND USAGE Paricalcitol Injection is an active vitamin D 2 analogue indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 5. Paricalcitol Injection is an active vitamin D 2 analog indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION For intravenous use through hemodialysis vascular access port only. The recommended starting dose of Paricalcitol Injection is 0.04 mcg/kg to 0.1 mcg/kg (2.8 – 7 mcg) administered through a hemodialysis vascular access port as a bolus dose at any time during dialysis. Dosing should not occur more frequently than every other day.

The drug product should not be injected directly into a vein. Dosage should be individualized. If a satisfactory parathyroid hormone (PTH) lowering response is not observed using the recommended starting dose, the dose may be increased by 2 to 4 mcg every 2 to 4 weeks based on PTH levels (refer to Table 1).

Table 1: Suggested Dosage Adjustment PTH Level at Follow-up Visit Dosage Adjustment Above target and PTH increased Increase Above target and PTH decreased by less than 30% Increase Above target and PTH decreased by 30 to 60% No Change Above target and PTH decreased by more than 60% Decrease At target and PTH stable No Change When initiating Paricalcitol Injection or adjusting Paricalcitol Injection dose, measure serum calcium and phosphorus frequently (e.g., twice weekly) and PTH every 2 to 4 weeks. Once a maintenance dose has been established, serum calcium and phosphorus should be measured at least monthly and plasma PTH every 3 months.

The recommended starting dose is 0.04 mcg/kg to 0.1 mcg/kg (2.8 – 7 mcg). Administer Paricalcitol Injection as a bolus through a hemodialysis vascular access port at any time during dialysis. Dosing should not occur more frequently than every other day.

Do not inject Paricalcitol Injection directly into a vein. Paricalcitol Injection dose should be individualized. If a satisfactory PTH lowering response is not observed with the initial dose, the dose may be increased by 2 to 4 mcg at 2- to 4- week intervals based on parathyroid hormone (PTH) levels.

( 2 ) Suggested Dosage Adjustment PTH Level at Follow-up Visit Dosage Adjustment Above target and PTH increased Increase Above target and PTH decreased by less than 30% Increase Above target and PTH decreased by 30 to 60% No Change Above target and PTH decreased by more than 60% Decrease At target and PTH stable No Change

💊 Dosage Forms and Strengths 76 words ▾

3 DOSAGE FORMS AND STRENGTHS Paricalcitol Injection is available in the following presentations: 2 mcg per mL single dose vial 5 mcg per mL single dose vial 10 mcg per 2 mL (5 mcg per mL) multiple dose vial Paricalcitol Injection is available in the following presentations: 2 mcg per mL single dose vial, 5 mcg per mL single dose vial, 10 mcg per 2 mL (5 mcg per mL) multiple dose vial. ( 3 )

⛔ Contraindications 60 words ▾

4 CONTRAINDICATIONS Paricalcitol Injection is contraindicated in patients with evidence of: Hypercalcemia [see Warnings and Precautions ( 5.1 ) ] Vitamin D toxicity [see Warnings and Precautions ( 5.1 ) ] or Hypersensitivity to paricalcitol or any inactive ingredient in this product [see Adverse Reactions ( 6.2 ) ] Evidence of hypercalcemia, vitamin D toxicity or hypersensitivity. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypercalcemia : The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or metabolically inactive or active forms of vitamin D. Monitor serum calcium when using Paricalcitol Injection and adjust dose accordingly. ( 5.1 ) Digitalis Toxicity : Hypercalcemia increases the risk of digitalis toxicity.

In patients using Paricalcitol Injection concomitantly with digitalis compounds, monitor both serum calcium and patients for signs and symptoms of digitalis toxicity and increase frequency of monitoring when initiating or adjusting the dose of Paricalcitol Injection. ( 5.2 ) Risk of Increased Paricalcitol Levels With Concomitant Use of Strong CYP3A Inhibitors : Use of Paricalcitol Injection with strong CYP3A inhibitors increases the concentration of paricalcitol in the blood. In patients on Paricalcitol Injection who are initiating or discontinuing drugs known to be strong CYP3A inhibitors, monitor serum calcium and PTH more frequently and adjust Paricalcitol Injection dose as required.

( 5.3 ) Adynamic Bone Disease : May develop if PTH levels are suppressed to abnormally low levels. Monitor PTH levels and adjust Paricalcitol Injection accordingly. ( 5.4 )

5.1Hypercalcemia Hypercalcemia may occur during Paricalcitol Injection treatment and may be exacerbated by concomitant administration of high doses of calcium containing preparations, thiazide diuretics, or vitamin D (i.e., all forms). Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the effect of digitalis on the heart. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification.

Hypercalcemia may be so severe as to require emergency attention. High intake of calcium and phosphate concomitantly with vitamin D compounds may lead to hypercalcemia, hypercalciuria, and hyperphosphatemia. Prevention of such adverse reactions requires frequent serum calcium monitoring and careful Paricalcitol Injection dose adjustments.

Concomitant use with other active vitamin D analogues should be avoided during Paricalcitol Injection treatment to prevent hypercalcemia. Patients also should be informed about the symptoms of elevated calcium, which include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss.

5.2Digitalis Toxicity Hypercalcemia of any cause increases the risk of digitalis toxicity. In patients using Paricalcitol Injection concomitantly with digitalis compounds, monitor both serum calcium and patients for signs and symptoms of digitalis toxicity and increase frequency of monitoring when initiating or adjusting the dose of Paricalcitol Injection [see Dosage and Administration ( 2 ) ].

5.3Risk of Increased Paricalcitol Levels With Concomitant Use of Strong CYP3A Inhibitors Concomitant use of Paricalcitol Injection with strong CYP3A inhibitors will increase the levels of paricalcitol in the blood. In patients on Paricalcitol Injection who are initiating or discontinuing therapy with drugs known to be strong CYP3A inhibitors, monitor serum calcium and PTH more frequently and adjust Paricalcitol Injection dose as required [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 ) ].

5.4Adynamic Bone Disease Adynamic bone disease with subsequent increased risk of fractures may develop if PTH levels are suppressed to abnormally low levels. Monitor PTH levels and adjust Paricalcitol Injection dose [see Dosage and Administration ( 2 ) ].

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (greater than 5% and more frequent than placebo) include nausea, vomiting and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Safety has been evaluated in clinical studies conducted with another paricalcitol injection product in 609 patients with CKD Stage 5. In four, placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in 6.5% of 62 patients treated with paricalcitol injection (dosage titrated as tolerated, [see Clinical Studies ( 14 ) ]) and 2% of 51 patients treated with placebo for 1 to 3 months.

Adverse reactions occurring with greater frequency in the paricalcitol group and at a frequency of 2% or greater are presented in the following table: Table 2: Adverse Reactions Occurring at a Rate A patient who reported the same medical term more than once was counted only once for that medical term. of 2% or Greater in CKD Stage 5 Patients in Four Placebo-Controlled Studies Adverse Reaction Placebo (n=51) % Paricalcitol Injection (n=62) % Cardiac Disorders Palpitations 0.0

3.2Gastrointestinal Disorders Nausea 7.8

12.9Vomiting 5.9

8.1Gastrointestinal Hemorrhage 2.0

4.8Dry Mouth 2.0

3.2General Disorders and Administration Site Conditions Edema 0.0

6.5Chills 2.0

4.8Pyrexia 2.0

4.8Malaise 0.0

3.2Infections and Infestations Pneumonia 0.0

4.8Sepsis 2.0

4.8Influenza 3.9

4.8Musculoskeletal and Connective Tissue Disorders Arthralgia 3.9

4.8Specific laboratory parameters [i.e., changes in mean Calcium (Ca), Phosphorus (P), and Calcium Phosphorus product (Ca × P)] were followed in an open-label safety study conducted with another paricalcitol injection product for up to 13 months in duration in this patient population and results are shown below [see Clinical Studies ( 14 ) ]. Other Adverse Reactions Associated with Paricalcitol Injection Use The following adverse reactions occurred in less than 2% of the paricalcitol-treated patients in the above mentioned double-blind, placebo-controlled clinical trials and in additional double-blind, active-controlled and open-label studies: Blood and Lymphatic System Disorders: Anemia, lymphadenopathy Cardiac Disorders: Arrhythmia, atrial flutter, cardiac arrest Ear and Labyrinth Disorders: Ear discomfort Endocrine Disorders: Hypoparathyroidism Eye Disorders: Conjunctivitis, glaucoma, ocular hyperemia Gastrointestinal Disorders: Abdominal discomfort, constipation, diarrhea, dysphagia, gastritis, intestinal ischemia, rectal hemorrhage General Disorders and Administration Site Conditions: Asthenia, chest discomfort, chest pain, condition aggravated, edema peripheral, fatigue, feeling abnormal, gait disturbance, injection site extravasation, injection site pain, pain, swelling, thirst Infections and Infestations: Nasopharyngitis, upper respiratory tract infection, vaginal infection Laboratory Investigations and Vital Signs: Increased aspartate aminotransferase, prolonged bleeding time, irregular heart rate, decreased weight Metabolism and Nutrition Disorders: Decreased appetite, hypercalcemia, hyperkalemia, hyperphosphatemia, hypocalcemia Musculoskeletal and Connective Tissue Disorders: Joint stiffness, muscle twitching, myalgia Neoplasms Benign, Malignant and Unspecified : Breast cancer Nervous System Disorders: Cerebrovascular accident, dizziness, dysgeusia, headache, hypoesthesia, myoclonus, paresthesia, syncope, unresponsive to stimuli Psychiatric Disorders: Agitation, confusional state, delirium, insomnia, nervousness, restlessness Reproductive System and Breast Disord… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 81 words ▾

7 DRUG INTERACTIONS Co-administration with strong CYP3A inhibitors (e.g. ketoconazole) increases paricalcitol blood levels. See WARNINGS AND PRECAUTIONS. ( 5.3 , 7.1 )

7.1Strong CYP3A Inhibitors Paricalcitol is partially metabolized by CYP3A. Paricalcitol blood levels will be increased when paricalcitol is co-administered with strong CYP3A inhibitors. If a patient initiates or discontinues therapy with a strong CYP3A inhibitor, monitor both PTH and serum calcium more frequently and adjust Paricalcitol Injection dose as required [see Clinical Pharmacology ( 12.3 ) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Use during pregnancy only if the potential benefit justifies the potential risk. ( 8.1 ) Nursing Mothers : A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. ( 8.3 )

8.1Pregnancy Pregnancy Category C Paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times the 0.24 mcg/kg human dose (based on surface area, mg/m 2 ) and when administered to rats at a dose 2 times the 0.24 mcg/kg human dose (based on plasma levels of exposure). At the highest dose tested (20 mcg/kg 3 times per week in rats, 13 times the 0.24 mcg/kg human dose based on surface area), there was a significant increase of the mortality of newborn rats at doses that were maternally toxic (hypercalcemia).

No other effects on offspring development were observed. Paricalcitol was not teratogenic at the doses tested. There are no adequate and well-controlled studies in pregnant women.

Paricalcitol Injection should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

8.3Nursing Mothers Studies in rats have shown that paricalcitol is present in the milk. It is not known whether paricalcitol is excreted in human milk. In the nursing patient, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use The safety and effectiveness of paricalcitol injection were examined with another paricalcitol injection product in a 12-week randomized, double-blind, placebo-controlled study of 29 pediatric patients, aged 5-19 years, with end-stage renal disease on hemodialysis and nearly all had received some form of vitamin D prior to the study. Seventy-six percent of the patients were male, 52% were Caucasian and 45% were African-American. The initial dose of paricalcitol injection was 0.04 mcg/kg 3 times per week based on baseline iPTH level of less than 500 pg/mL, or 0.08 mcg/kg 3 times a week, based on baseline iPTH level of ≥ 500 pg/mL, respectively.

The dose of paricalcitol injection was adjusted in 0.04 mcg/kg increments based on the levels of serum iPTH, calcium and Ca x P. The mean baseline levels of iPTH were 841 pg/mL for the 15 paricalcitol injection-treated patients and 740 pg/mL for the 14 placebo-treated subjects. The mean dose of paricalcitol injection administered was 4.6 mcg (range: 0.8 mcg-9.6 mcg).

Ten of the 15 (67%) paricalcitol injection-treated patients and 2 of the 14 (14%) placebo-treated patients completed the trial. Ten of the placebo patients (71%) were discontinued due to excessive elevations in iPTH levels as defined by 2 consecutive iPTH levels > 700 pg/mL and greater than baseline after 4 weeks of treatment. In the primary efficacy analysis, 9 of 15 (60%) subjects in the paricalcitol injection group had 2 consecutive 30% decreases from baseline iPTH compared with 3 of 14 (21%) patients in the placebo group (95% CI for the difference between groups -1%, 63%).

Twenty-three percent of paricalcitol injection vs. 31% of placebo patients had at least one serum calcium level > 10.3 mg/dL and 40% vs. 14% of paricalcitol injection vs. placebo subjects had at least one Ca x P ion product > 72 (mg/dL) 2 .

The overall percentage of serum calcium measurements >10.3 mg/dL was 7% in the paricalcitol injection group and 7% in the placebo group; the overall percentage of patients with Ca x P product >72 (mg/dL) 2 was 8% in the paricalcitol injection group and 7% in the placebo group. No subjects in either the paricalcitol injection group or placebo group developed hypercalcemia (defined as at least one calcium value > 11.2 mg/dL) during the study.

8.5Geriatric Use Clinical studies of paricalcitol injection did not include sufficient numbers of subjects aged 65 and over to determine whether they resp… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 150 words ▾

8.1Pregnancy Pregnancy Category C Paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times the 0.24 mcg/kg human dose (based on surface area, mg/m 2 ) and when administered to rats at a dose 2 times the 0.24 mcg/kg human dose (based on plasma levels of exposure). At the highest dose tested (20 mcg/kg 3 times per week in rats, 13 times the 0.24 mcg/kg human dose based on surface area), there was a significant increase of the mortality of newborn rats at doses that were maternally toxic (hypercalcemia).

No other effects on offspring development were observed. Paricalcitol was not teratogenic at the doses tested. There are no adequate and well-controlled studies in pregnant women.

Paricalcitol Injection should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of paricalcitol injection were examined with another paricalcitol injection product in a 12-week randomized, double-blind, placebo-controlled study of 29 pediatric patients, aged 5-19 years, with end-stage renal disease on hemodialysis and nearly all had received some form of vitamin D prior to the study. Seventy-six percent of the patients were male, 52% were Caucasian and 45% were African-American. The initial dose of paricalcitol injection was 0.04 mcg/kg 3 times per week based on baseline iPTH level of less than 500 pg/mL, or 0.08 mcg/kg 3 times a week, based on baseline iPTH level of ≥ 500 pg/mL, respectively.

The dose of paricalcitol injection was adjusted in 0.04 mcg/kg increments based on the levels of serum iPTH, calcium and Ca x P. The mean baseline levels of iPTH were 841 pg/mL for the 15 paricalcitol injection-treated patients and 740 pg/mL for the 14 placebo-treated subjects. The mean dose of paricalcitol injection administered was 4.6 mcg (range: 0.8 mcg-9.6 mcg).

Ten of the 15 (67%) paricalcitol injection-treated patients and 2 of the 14 (14%) placebo-treated patients completed the trial. Ten of the placebo patients (71%) were discontinued due to excessive elevations in iPTH levels as defined by 2 consecutive iPTH levels > 700 pg/mL and greater than baseline after 4 weeks of treatment. In the primary efficacy analysis, 9 of 15 (60%) subjects in the paricalcitol injection group had 2 consecutive 30% decreases from baseline iPTH compared with 3 of 14 (21%) patients in the placebo group (95% CI for the difference between groups -1%, 63%).

Twenty-three percent of paricalcitol injection vs. 31% of placebo patients had at least one serum calcium level > 10.3 mg/dL and 40% vs. 14% of paricalcitol injection vs. placebo subjects had at least one Ca x P ion product > 72 (mg/dL) 2 .

The overall percentage of serum calcium measurements >10.3 mg/dL was 7% in the paricalcitol injection group and 7% in the placebo group; the overall percentage of patients with Ca x P product >72 (mg/dL) 2 was 8% in the paricalcitol injection group and 7% in the placebo group. No subjects in either the paricalcitol injection group or placebo group developed hypercalcemia (defined as at least one calcium value > 11.2 mg/dL) during the study.

🧓 Geriatric Use 84 words ▾

8.5Geriatric Use Clinical studies of paricalcitol injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 96 words ▾

10 OVERDOSAGE Overdosage of Paricalcitol Injection may lead to hypercalcemia, hypercalciuria, hyperphosphatemia, and oversuppression of PTH resulting in adynamic bone disease. [see Warnings and Precautions ( 5 .1 , 5.4 ) ].

10.1Treatment of Overdosage and Hypercalcemia The treatment of acute overdosage should consist of supportive measures, discontinuation of drug administration and supplemental calcium, institution of a low calcium diet. Serum calcium levels should be measured until normocalcemia ensues. When serum calcium levels have returned to within normal limits, Paricalcitol Injection may be reinitiated at a lower dose.

Paricalcitol is not significantly removed by dialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the vitamin D receptor (VDR), which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.

12.3Pharmacokinetics Within two hours after administering paricalcitol intravenous doses ranging from 0.04 to 0.24 mcg/kg, concentrations of paricalcitol decreased rapidly; thereafter, concentrations of paricalcitol declined log-linearly. No accumulation of paricalcitol was observed with three times a week dosing. Distribution : Paricalcitol is extensively bound to plasma proteins (≥ 99.8%).

In healthy subjects, the steady state volume of distribution is approximately

23.8L. The mean apparent volume of distribution following a 0.24 mcg/kg dose of paricalcitol in CKD Stage 5 subjects requiring hemodialysis (HD) and peritoneal dialysis (PD) is between 31 and 35 L. Metabolism : After intravenous administration of a 0.48 mcg/kg dose of 3 H-paricalcitol, parent drug was extensively metabolized, with only about 2% of the dose eliminated unchanged in the feces and no parent drug found in the urine.

Several metabolites were detected in both the urine and feces. Most of the systemic exposure was from the parent drug. Two minor metabolites, relative to paricalcitol, were detected in human plasma.

One metabolite was identified as 24(R)-hydroxy paricalcitol, while the other metabolite was unidentified. The 24(R)-hydroxy paricalcitol is less active than paricalcitol in an in vivo rat model of PTH suppression. In vitro data suggest that paricalcitol is metabolized by multiple hepatic and non-hepatic enzymes, including mitochondrial CYP24, as well as CYP3A4 and UGT1A4.

The identified metabolites include the product of 24(R)-hydroxylation (present at low levels in plasma), as well as 24,26- and 24,28-dihydroxylation and direct glucuronidation. Elimination : Paricalcitol is excreted primarily by hepatobiliary excretion. Approximately 63% of a radioactive dose was recovered in the feces and 19% was recovered in the urine in healthy subjects.

In healthy subjects, the mean elimination half-life of paricalcitol is about five to seven hours over the studied dose range of 0.04 to 0.16 mcg/kg. The pharmacokinetics of paricalcitol has been studied in CKD Stage 5 subjects requiring hemodialysis (HD) and peritoneal dialysis (PD). The mean elimination half-life of paricalcitol after administration of 0.24 mcg/kg paricalcitol intravenous bolus dose in CKD Stage 5 HD and PD patients is 13.9 and 15.4 hours, respectively (Table 3).

Table 3: Mean ± SD Paricalcitol Pharmacokinetic Parameters in CKD Stage 5 Subjects Following Single 0.24 mcg/kg Intravenous Bolus Dose CKD Stage 5 HD n = 14 CKD Stage 5 PD n = 8 C max (ng/mL) 1.680 ± 0.511 1.832 ± 0.315 AUC 0-∞ (ng•h/mL) 14.51 ± 4.12 16.01 ± 5.98 β (1/h) 0.050 ± 0.023 0.045 ± 0.026 t 1/2 (h) harmonic mean ± pseudo standard deviation, HD: hemodialysis, PD: peritoneal dialysis. The degree of accumulation was consistent with the half-life and dosing frequency. 13.9 ± 7.3 15.4 ±

10.5CL (L/h) 1.49 ± 0.60 1.54 ±

0.95Vd β (L) 30.8 ± 7.5 34.9 ±

9.5Specific Populations Geriatric : The pharmacokinetics of paricalcitol has not been investigated in geriatric patients greater than 65 years. Pediatric : The pharmacokinetics of paricalcitol has not been investigated in patients less than 18 years of age. Gender : The pharmacokinetics of paricalcitol was gender independent.

Hepatic Impairment : The disposition of intravenous paricalcitol (0.24 mcg/kg) was compared in patients with mild (n=5) and moderate (n=5) hepatic impairment (as indicated by the Child-Pugh method) and subjects with normal hepatic function (n=10). The pharmacokinetics of unbound paricalcitol was similar across the range of hepatic function evaluated in this stud… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 54 words ▾

12.1Mechanism of Action Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the vitamin D receptor (VDR), which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.

📦 How Supplied / Storage and Handling 145 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Paricalcitol Injection is available in 2 mcg/mL single dose vials (NDC 0143-9625-25), 5 mcg/mL single dose vials (NDC 0143-9624-25) and 10 mcg/2 mL (5 mcg/mL) multiple dose vials (NDC 0143-9596-25) in cartons of 25 vials. NDC Number Volume/Container Concentration Total Content Vial Type 0143-9625-25 1 mL/Fliptop Vial 2 mcg/mL 2 mcg Single Dose 0143-9624-25 1 mL/Fliptop Vial 5 mcg/mL 5 mcg Single Dose 0143-9596-25 2 mL/Fliptop Vial 5 mcg/mL 10 mcg Multiple Dose Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Do not freeze. After initial vial use, the contents of the multiple dose vial remain stable up to seven days when stored at controlled room temperature. Discard unused portion of the single dose vial.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

📋 Description 77 words ▾

11 DESCRIPTION Paricalcitol, USP, the active ingredient in Paricalcitol Injection, is a synthetically manufactured active vitamin D 2 analog. It is a white powder chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula: Paricalcitol Injection is available as a sterile, clear, colorless, aqueous solution for intravenous injection. Each mL contains paricalcitol 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 35% (v/v) and 70% sorbitol solution 7% (v/v) in water for injection. chemical structure

💬 Information for Patients 172 words ▾

17 PATIENT COUNSELING INFORMATION Patients should be advised: of the most common adverse reactions with use of Paricalcitol Injection, which include nausea, vomiting and fluid retention. to adhere to instructions regarding diet and phosphorus restriction. to contact a health care provider if they develop symptoms of elevated calcium, (e.g. feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss). to return to their dialysis clinic/health care provider’s office for routine monitoring.

More frequent monitoring is necessary during the initiation of therapy, following dose changes or when potentially interacting medications are started or discontinued. to inform their health care provider of all medications, including prescription and nonprescription drugs, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their health care provider prescribing a new medication that they are taking Paricalcitol Injection. Manufactured by: Exela Pharma Sciences, LLC Lenoir, NC 28645 USA Distributed by: WEST-WARD PHARMACEUTICAL CORP.

Eatontown, NJ 07724 USA 9625-0415-00 April 2015

🍼 Nursing Mothers 55 words ▾

8.3Nursing Mothers Studies in rats have shown that paricalcitol is present in the milk. It is not known whether paricalcitol is excreted in human milk. In the nursing patient, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Within two hours after administering paricalcitol intravenous doses ranging from 0.04 to 0.24 mcg/kg, concentrations of paricalcitol decreased rapidly; thereafter, concentrations of paricalcitol declined log-linearly. No accumulation of paricalcitol was observed with three times a week dosing. Distribution : Paricalcitol is extensively bound to plasma proteins (≥ 99.8%).

In healthy subjects, the steady state volume of distribution is approximately

23.8L. The mean apparent volume of distribution following a 0.24 mcg/kg dose of paricalcitol in CKD Stage 5 subjects requiring hemodialysis (HD) and peritoneal dialysis (PD) is between 31 and 35 L. Metabolism : After intravenous administration of a 0.48 mcg/kg dose of 3 H-paricalcitol, parent drug was extensively metabolized, with only about 2% of the dose eliminated unchanged in the feces and no parent drug found in the urine.

Several metabolites were detected in both the urine and feces. Most of the systemic exposure was from the parent drug. Two minor metabolites, relative to paricalcitol, were detected in human plasma.

One metabolite was identified as 24(R)-hydroxy paricalcitol, while the other metabolite was unidentified. The 24(R)-hydroxy paricalcitol is less active than paricalcitol in an in vivo rat model of PTH suppression. In vitro data suggest that paricalcitol is metabolized by multiple hepatic and non-hepatic enzymes, including mitochondrial CYP24, as well as CYP3A4 and UGT1A4.

The identified metabolites include the product of 24(R)-hydroxylation (present at low levels in plasma), as well as 24,26- and 24,28-dihydroxylation and direct glucuronidation. Elimination : Paricalcitol is excreted primarily by hepatobiliary excretion. Approximately 63% of a radioactive dose was recovered in the feces and 19% was recovered in the urine in healthy subjects.

In healthy subjects, the mean elimination half-life of paricalcitol is about five to seven hours over the studied dose range of 0.04 to 0.16 mcg/kg. The pharmacokinetics of paricalcitol has been studied in CKD Stage 5 subjects requiring hemodialysis (HD) and peritoneal dialysis (PD). The mean elimination half-life of paricalcitol after administration of 0.24 mcg/kg paricalcitol intravenous bolus dose in CKD Stage 5 HD and PD patients is 13.9 and 15.4 hours, respectively (Table 3).

Table 3: Mean ± SD Paricalcitol Pharmacokinetic Parameters in CKD Stage 5 Subjects Following Single 0.24 mcg/kg Intravenous Bolus Dose CKD Stage 5 HD n = 14 CKD Stage 5 PD n = 8 C max (ng/mL) 1.680 ± 0.511 1.832 ± 0.315 AUC 0-∞ (ng•h/mL) 14.51 ± 4.12 16.01 ± 5.98 β (1/h) 0.050 ± 0.023 0.045 ± 0.026 t 1/2 (h) harmonic mean ± pseudo standard deviation, HD: hemodialysis, PD: peritoneal dialysis. The degree of accumulation was consistent with the half-life and dosing frequency. 13.9 ± 7.3 15.4 ±

10.5CL (L/h) 1.49 ± 0.60 1.54 ±

0.95Vd β (L) 30.8 ± 7.5 34.9 ±

9.5Specific Populations Geriatric : The pharmacokinetics of paricalcitol has not been investigated in geriatric patients greater than 65 years. Pediatric : The pharmacokinetics of paricalcitol has not been investigated in patients less than 18 years of age. Gender : The pharmacokinetics of paricalcitol was gender independent.

Hepatic Impairment : The disposition of intravenous paricalcitol (0.24 mcg/kg) was compared in patients with mild (n=5) and moderate (n=5) hepatic impairment (as indicated by the Child-Pugh method) and subjects with normal hepatic function (n=10). The pharmacokinetics of unbound paricalcitol was similar across the range of hepatic function evaluated in this study. No dosing adjustment is required in patients with mild and moderate hepatic impairment.

The influence of severe hepatic impairment on the pharmacokinetics of paricalcitol has not been evaluated. Renal Impairment : The pharmacokinetics of paricalcitol has been studied in CKD Stage 5 subjects requiring hemodialysis (HD) and peritoneal dialysis (PD). Hemodialysis procedure has essentially no effect… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES In three 12-week, placebo-controlled, phase 3 studies conducted with another paricalcitol injection product in patients with Stage 5 chronic kidney disease on dialysis, the dose of paricalcitol was started at 0.04 mcg/kg 3 times per week. The dose was increased by 0.04 mcg/kg every 2 weeks until intact parathyroid hormone (iPTH) levels were decreased at least 30% from baseline, or a fifth escalation brought the dose to 0.24 mcg/kg, or iPTH fell to less than 100 pg/mL, or the Ca x P product was greater than 75 within any 2 week period, or serum calcium became greater than 11.5 mg/dL at any time.

Patients treated with paricalcitol achieved a mean iPTH reduction of 30% within 6 weeks. In these studies, there was no significant difference in the incidence of hypercalcemia or hyperphosphatemia between paricalcitol and placebo-treated patients. The results from these studies are as follows: Table 4: Mean Changes from Baseline to Final Evaluation in PTH, Alkaline Phosphatase, Phosphorus and Calcium x Phosphorus Product in CKD Stage 5 Patients in Three Placebo-Controlled, Phase 3 Studies Group (No. of Pts.) Baseline Mean (Range) Mean (SE) Change From Baseline to Final Evaluation PTH (pg/mL) paricalcitol (n=40) 783 (291–2076) -379 (43.7) placebo (n=38) 745 (320 – 1671) -69.6 (44.8) Alkaline Phosphatase (U/L) paricalcitol (n=31) 150 (40 – 600) -41.5 (10.6) placebo (n=34) 169 (56 – 911) +2.6 (10.1) Phosphorus (mg/dL) paricalcitol (n=40) 5.8 (3.7 – 10.2) +0.47 (0.3) placebo (n=38) 6.0 (2.8 – 8.8) -0.47 (0.3) Calcium x Phosphorus Product paricalcitol (n=40) 54 (32 – 106) +7.9 (2.2) placebo (n=38) 54 (26 – 77) -3.9 (2.3) A long-term, open-label safety study of 164 CKD Stage 5 patients conducted with another paricalcitol injection product (mean dose of 7.5 mcg three times per week), demonstrated that mean serum Ca, P, and Ca x P remained within clinically appropriate ranges with PTH reduction (mean decrease of 319 pg/mL at 13 months).

Figure 1: Mean Values for Serum iPTH, Calcium and Phosphorus Over Time in CKD Stage 5 Patients in a Phase 3 Study Figure 1: Mean Values for Serum iPTH, Calcium and Phosphorus Over Time in CKD Stage 5 Patients in a Phase 3 Study

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week carcinogenicity study in CD-1 mice conducted with paricalcitol, an increased incidence of uterine leiomyoma and leiomyosarcoma was observed at subcutaneous doses of 1, 3, 10 mcg/kg (2 to 15 times the AUC at a human dose of 14 mcg, equivalent to 0.24 mcg/kg based on AUC). The incidence rate of uterine leiomyoma was significantly different than the control group at the highest dose of 10 mcg/kg. In a 104-week carcinogenicity study in rats conducted with paricalcitol, there was an increased incidence of benign adrenal pheochromocytoma at subcutaneous doses of 0.15, 0.5, 1.5 mcg/kg (< 1 to 7 times the exposure following a human dose of 14 mcg, equivalent to 0.24 mcg/kg based on AUC).

The increased incidence of pheochromocytomas in rats may be related to the alteration of calcium homeostasis by paricalcitol. Paricalcitol did not exhibit genetic toxicity in vitro with or without metabolic activation in the microbial mutagenesis assay (Ames Assay), mouse lymphoma mutagenesis assay (L5178Y), or a human lymphocyte cell chromosomal aberration assay. There was also no evidence of genetic toxicity in an in vivo mouse micronucleus assay.

Paricalcitol had no effect on fertility (male or female) in rats at intravenous doses up to 20 mcg/kg/dose [equivalent to 13 times the highest recommended human dose (0.24 mcg/kg) based on surface area, mg/m 2 ].

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week carcinogenicity study in CD-1 mice conducted with paricalcitol, an increased incidence of uterine leiomyoma and leiomyosarcoma was observed at subcutaneous doses of 1, 3, 10 mcg/kg (2 to 15 times the AUC at a human dose of 14 mcg, equivalent to 0.24 mcg/kg based on AUC). The incidence rate of uterine leiomyoma was significantly different than the control group at the highest dose of 10 mcg/kg. In a 104-week carcinogenicity study in rats conducted with paricalcitol, there was an increased incidence of benign adrenal pheochromocytoma at subcutaneous doses of 0.15, 0.5, 1.5 mcg/kg (< 1 to 7 times the exposure following a human dose of 14 mcg, equivalent to 0.24 mcg/kg based on AUC).

The increased incidence of pheochromocytomas in rats may be related to the alteration of calcium homeostasis by paricalcitol. Paricalcitol did not exhibit genetic toxicity in vitro with or without metabolic activation in the microbial mutagenesis assay (Ames Assay), mouse lymphoma mutagenesis assay (L5178Y), or a human lymphocyte cell chromosomal aberration assay. There was also no evidence of genetic toxicity in an in vivo mouse micronucleus assay.

Paricalcitol had no effect on fertility (male or female) in rats at intravenous doses up to 20 mcg/kg/dose [equivalent to 13 times the highest recommended human dose (0.24 mcg/kg) based on surface area, mg/m 2 ].

📄 Package Label / Principal Display Panel 133 words ▾

PRINCIPAL DISPLAY PANEL NDC 0143-9625-01 Rx only Paricalcitol Injection 2 mcg/mL Discard unused portion 1 mL Single Dose Vial For 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

PRINCIPAL DISPLAY PANEL NDC 0143-9624-01 Rx only Paricalcitol Injection 5 mcg/mL Discard unused portion 1 mL Single Dose Vial For 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

PRINCIPAL DISPLAY PANEL NDC 0143-9596-01 Rx only Paricalcitol Injection 10 mcg/2 mL (5 mcg/mL) 2 mL Multiple Dose Vial For 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

SERIALIZATION IMAGE LAYOUT 1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Paricalcitol — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Paricalcitol. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$589.3K
Claims incl. refills
7.3K
Beneficiaries
4.1K
Spend / beneficiary
$143.02
Spend / claim
$80.84
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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HCPCS J-code billing crosswalk ✓ Available
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by West-Ward Pharmaceuticals Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
West-Ward Pharmaceuticals Corp is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2501 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00143-9624-25 · West-Ward 00143-9633-10 · Hikma →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.