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Cinacalcet 30 mg Tablet, Film Coated, 500-count — NDC 84386-0111-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cinacalcet 30 mg Tablet, Film Coated, 500-count — NDC 84386-111-05 (Billing 84386-0111-05)

by Aurobindo Pharma Limited · 500 TABLET, FILM COATED in 1 BOTTLE

This is a package of 500 tablets of Cinacalcet 30 mg Tablet, Film Coated from Aurobindo Pharma Limited, marketed since Mar 2026 and currently FDA-listed.

NDC 84386-0111-05
🏷️ FDA NDC (as labeled) 84386-111-05 billing pads the product segment with a zero
This package
Contains500-count Pack sizes4 compare ↓
Product page 84386-0111-01 Also comes in: 30 tablets 84386-111-30 90 tablets 84386-111-90 100 tablets 84386-111-01
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Cinacalcet (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 29, 2026 — cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). (Cipla USA, Inc.) · FDA recall D-0675-2026
Class II · Jun 29, 2026 — cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). (Cipla USA, Inc.) · FDA recall D-0676-2026
Class II · Jun 29, 2026 — cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). (Cipla USA, Inc.) · FDA recall D-0661-2026
Class II · Mar 16, 2026 — CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit (Cipla USA, Inc.) · FDA recall D-0451-2026
Class II · Mar 16, 2026 — CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit (Cipla USA, Inc.) · FDA recall D-0449-2026
Class II · Mar 16, 2026 — CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit (Cipla USA, Inc.) · FDA recall D-0450-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84386-111-05
Product NDC 84386-111
11-digit billing NDC 84386011105
RxCUI 432400, 432401, 432402
UNII 1K860WSG25
UPC 0384386111308, 0384386113302, 0384386112305
Application # ANDA206125
SPL Set ID 200390f2-7dad-4ecc-a086-c29e18525c01
Established class (EPC) Calcium-sensing Receptor Agonist
Mechanism of action Increased Calcium-sensing Receptor Sensitivity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-23
Route ORAL
Dosage form TABLET, FILM COATED
Substance CINACALCET HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 432400
Why two NDCs? The FDA registers this code as 84386-111-05 — a 5-3-2 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 product segment → 84386-0111-05. 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 Calcium-sensing Receptor Agonist class.

Pharmacologic class Calcium-sensing Receptor Agonist
Drug family (ATC) Other anti-parathyroid agents
How it works Increased Calcium-sensing Receptor Sensitivity
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

📖 What it is MedlinePlus · NLM

Cinacalcet is used to treat hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [a natural substance needed to control the amount of calcium in the blood] which can cause serious problems with the bones, heart, blood vessels, and lungs) in people with chronic kidney disease (condition in which the kidneys stop working slowly and gradually) who are being treated with dialysis. Cinacalcet is also used to treat high levels of calcium in the blood of patients who have parathyroid cancer (cancer of the glands in the neck that make parathyroid hormone). Cinacalce...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It lowers parathyroid hormone and blood calcium. It's used in adults with secondary hyperparathyroidism on dialysis, in parathyroid carcinoma, and in primary hyperparathyroidism wh...
  • Take it by mouth with food or right after a meal. Swallow it whole. Don't chew, crush or split it. Your prescriber may change your amount based on blood tests, so keep your lab app...
  • Nausea and vomiting are the most common, and taking it with food helps. Diarrhea, muscle aches, dizziness and headache can also happen. If nausea or vomiting is severe or won't sto...
  • Call right away for tingling, muscle cramps or spasms, seizures, a racing or irregular heartbeat, or fainting. These can be signs of low calcium. Also call for black or bloody stoo...
📖 Read our full Cinacalcet 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 tablets 90 tablets 100 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84386-0111-01 84386-111-01 Main listing 100 TABLET, FILM COATED in 1 BOTTLE 2026-03-23 — Active
84386-0111-05 You're viewing this 500 TABLET, FILM COATED in 1 BOTTLE 2026-03-23 — Active
84386-0111-30 84386-111-30 30 TABLET, FILM COATED in 1 BOTTLE 2026-03-23 — Active
84386-0111-90 84386-111-90 90 TABLET, FILM COATED in 1 BOTTLE 2026-03-23 — Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet, film coated in 1 bottle.
How does this package differ from NDC 84386-0111-30?
Both are Cinacalcet 30 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 500-count one, while NDC 84386-0111-30 is the 30 tablets package.
What NDC number is used to bill for this package of Cinacalcet 30 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cinacalcet 30 mg 00904-7502-04 Major 1 tablet $0.402 AB Availability likely —
Cinacalcet 30 mg 31722-0103-30 Camber 30 tablets $0.402 — Availability likely —
Cinacalcet 30 mg 50268-0188-12 AvPAK 1 tablet $0.402 AB Availability likely —
Cinacalcet 30 mg 60687-0516-21 American 1 tablet $0.402 AB Availability likely —
Cinacalcet 30 mg 64380-0883-04 Strides 30 tablets $0.402 AB Availability likely —
Cinacalcet 30 mg 69097-0410-02 Cipla 30 tablets $0.402 AB Availability likely —
Cinacalcet 30 mg 76282-0674-30 EXELAN 30 tablets $0.402 AB Availability likely —
Cinacalcet 30 mg 47335-0379-83 Sun 30 tablets $0.403 — FDA listed —
Cinacalcet 30 mg 16729-0440-10 Accord 30 tablets $0.407 AB Availability likely —
Sensipar 30 mg 55513-0073-30 Amgen 30 tablets $26.189 — FDA listed —
Cinacalcet 30 mg 43598-0367-05 Dr. 500 tablets — AB FDA listed —
Cinacalcet 30 mg 63629-8763-01 Bryant 30 tablets — AB FDA listed —
Cinacalcet 30 mg 63629-9608-01 Bryant 30 tablets — AB FDA listed —
Cinacalcet Hydrochloride 30 mg 65162-0155-03 Amneal 30 tablets — — FDA listed —
Cinacalcet 30 mg 65862-0831-01 Aurobindo 100 tablets — AB Discontinued —
Cinacalcet 30 mg 67877-0503-01 Ascend 100 tablets — AB FDA listed —
Cinacalcet 30 mg 70518-4615-00 REMEDYREPACK 1 tablet — AB FDA listed —
Cinacalcet 30 mg 71335-2761-01 Bryant 30 tablets — AB FDA listed —
Cinacalcet 30 mg 72162-1843-03 Bryant 30 tablets — AB FDA listed —
Cinacalcet 30 mg 72865-0150-30 XLCare 30 tablets — — FDA listed —
Cinacalcet 30 mgthis 84386-0111-05 Aurobindo 500 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

What it looks like

Color Green
ShapeOval
Imprint82;Y
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

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

  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 36SFW2JZ0W
    Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

15 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

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA206125 (ANDA)
Labeler code84386
First marketedMar 2026
Product typeHuman Prescription Drug
Portfolio1,456 products on file
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. 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
🎯 Indications and Usage 220 words ▾

1 INDICATIONS AND USAGE Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1) Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy.

( 1.3 )

1.1Secondary Hyperparathyroidism Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (14.1) ]. Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions (5.1) ] .

1.2Parathyroid Carcinoma Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies (14.2) ] .

1.3Primary Hyperparathyroidism Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy [see Clinical Studies (14.3) ].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Cinacalcet tablets should be taken with food or shortly after a meal (2.1) Tablets should always be taken whole and not divided (2.1) Secondary HPT in patients with CKD on dialysis (2.2) : Starting dose is 30 mg once daily. Titrate dose no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily as necessary to achieve targeted intact parathyroid hormone (iPTH) levels. iPTH levels should be measured no earlier than 12 hours after most recent dose.

Hypercalcemia in patients with PC or hypercalcemia in patients with primary HPT (2.3) : Starting dose is 30 mg twice daily. Titrate dose every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to normalize serum calcium levels. Once the maintenance dose has been established, monitor serum calcium approximately monthly for patients with secondary HPT and every 2 months for patients with PC or primary HPT (2.4)

2.1Administration Cinacalcet tablets should be taken with food or shortly after a meal. Cinacalcet tablets are administered orally and should always be taken whole and not chewed, crushed, or divided.

2.2Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis The recommended starting oral dose of cinacalcet tablets is 30 mg once daily. Serum calcium and serum phosphorus should be measured within 1 week and intact parathyroid hormone (iPTH) should be measured 1 to 4 weeks after initiation or dose adjustment of cinacalcet tablets [see Dosage and Administration (2.3) ] . Cinacalcet tablets should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily to target iPTH levels of 150 to 300 pg/mL.

Serum iPTH levels should be assessed no earlier than 12 hours after dosing with cinacalcet tablets. Cinacalcet tablets can be used alone or in combination with vitamin D sterols and/or phosphate binders. During dose titration, serum calcium levels should be monitored frequently and if levels decrease below the normal range, appropriate steps should be taken to increase serum calcium levels, such as by providing supplemental calcium, initiating or increasing the dose of calcium-based phosphate binder, initiating or increasing the dose of vitamin D sterols, or temporarily withholding treatment with cinacalcet tablets [see Dosage and Administration (2.4) and Warnings and Precautions (5.1) ] .

2.3Patients with Parathyroid Carcinoma and Primary Hyperparathyroidism The recommended starting oral dose of cinacalcet tablets is 30 mg twice daily. The dose of cinacalcet tablets should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, and 90 mg twice daily, and 90 mg 3 or 4 times daily as necessary to normalize serum calcium levels. Serum calcium should be measured within 1 week after initiation or dose adjustment of cinacalcet tablets [see Dosage and Administration (2.4) and Warnings and Precautions (5.1) ].

2.4Switching from Parsabiv (etelcalcetide) to Cinacalcet Tablets Discontinue etelcalcetide for at least 4 weeks prior to starting cinacalcet tablets. Ensure corrected serum calcium is at or above the lower limit of normal prior to cinacalcet tablets initiation [see Warnings and Precautions (5.1) ]. Initiate cinacalcet tablets treatment at a starting dose of 30 mg once daily.

2.5Monitoring for Hypocalcemia Once the maintenance dose has been established, serum calcium should be measured approximately monthly for patients with secondary hyperparathyroidism with CKD on dialysis, and every 2 months for patients with parathyroid carcinoma or primary hyperparathyroidism [see Dosage and Administration (2.2 , 2.3) ]. For secondary hyperparathyroidism patients with CKD on dialysis, if serum calcium falls below 8.4 mg/dL but remains above 7.5 mg/dL, or if symptoms of hypocalcemia occur, calcium-co…

💊 Dosage Forms and Strengths 89 words ▾

3 DOSAGE FORMS AND STRENGTHS Cinacalcet tablets, 30 mg are light green, film-coated, oval shaped, biconvex tablets debossed with “80” on one side and “Y” on the other side. Cinacalcet tablets, 60 mg are light green, film-coated, oval shaped, biconvex tablets debossed with “81” on one side and “Y” on the other side. Cinacalcet tablets, 90 mg are light green, film-coated, oval shaped, biconvex tablets debossed with “82” on one side and “Y” on the other side.

Tablets: 30 mg, 60 mg, and 90 mg tablets ( 3 )

⛔ Contraindications 52 words ▾

4 CONTRAINDICATIONS Cinacalcet tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see Warnings and Precautions (5.1) ] . Cinacalcet tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range. ( 4 , 5.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypocalcemia: Life threatening events and fatal outcomes were reported. Hypocalcemia can prolong QT interval, lower the threshold for seizures, and cause hypotension, worsening heart failure, and/or arrhythmia. Monitor serum calcium carefully for the occurrence of hypocalcemia during treatment.

(2.4 , 5.1) Upper Gastrointestinal (GI) Bleeding: Patients with risk factors for upper GI bleeding may be at increased risk. Monitor patients and promptly evaluate and treat any suspected GI bleeding. (5.2) Hypotension, Worsening Heart Failure and/or Arrhythmias : In postmarketing safety surveillance, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia have been reported in patients with impaired cardiac function.

(5.3) Adynamic Bone Disease : May develop if iPTH levels are suppressed below 100 pg/mL. (5.4)

5.1Hypocalcemia Cinacalcet lowers serum calcium and can lead to hypocalcemia [see Adverse Reactions (6.1) ]. Significant lowering of serum calcium can cause paresthesias, myalgias, muscle spasms, tetany, seizures, QT interval prolongation and ventricular arrhythmia. Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with cinacalcet, including in pediatric patients.

The safety and effectiveness of cinacalcet have not been established in pediatric patients [see Pediatric Use (8.4) ]. Cinacalcet is not indicated for patients with CKD not on dialysis [see Indications and Usage (1) ]. In patients with secondary HPT and CKD not on dialysis, the long-term safety and efficacy of cinacalcet have not been established.

Clinical studies indicate that cinacalcet-treated patients with CKD not on dialysis have an increased risk for hypocalcemia compared with cinacalcet-treated patients with CKD on dialysis, which may be due to lower baseline calcium levels. In a phase 3 study of 32 weeks duration and including 404 patients with CKD not on dialysis (302 cinacalcet, 102 placebo), in which the median dose for cinacalcet was 60 mg per day at the completion of the study, 80% of cinacalcet-treated patients experienced at least one serum calcium value < 8.4 mg/dL compared with 5% of patients receiving placebo.

QT Interval Prolongation and Ventricular Arrhythmia Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with cinacalcet. Patients with congenital long QT syndrome, history of QT interval prolongation, family history of long QT syndrome or sudden cardiac death, and other conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due to cinacalcet.

Closely monitor corrected serum calcium and QT interval in patients at risk receiving cinacalcet. Seizures In clinical studies, seizures (primarily generalized or tonic-clonic) were observed in 1.4% (43/3049) of cinacalcet-treated patients and 0.7% (5/687) of placebo-treated patients. While the basis for the reported difference in seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels.

Monitor serum calcium levels in patients with seizure disorders receiving cinacalcet. Concurrent Administration with Other Calcium-Lowering Drug Products Concurrent administration of cinacalcet with calcium-lowering drugs including other calcium- sensing receptor agonists could result in severe hypocalcemia. Closely monitor serum calcium in patients receiving cinacalcet and concomitant therapies known to lower serum calcium levels.

Patient Education and Hypocalcemia Treatment Educate patients on the symptoms of hypocalcemia and advise them to contact a healthcare provider if they occur. If corrected serum calcium falls below the lower limit of normal or symptoms of h…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of labeling: Hypocalcemia [see Warnings and Precautions (5.1) ] Upper Gastrointestinal Bleeding [see Warnings and Precautions (5.2) ] Hypotension, Worsening Heart Failure and/or Arrhythmias [see Warnings and Precautions (5.3) ] Adynamic Bone Disease [see Warnings and Precautions (5.4) ] The most common adverse reactions (i.e., ≥ 25%) associated with cinacalcet were nausea and vomiting. (6) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis In three double-blind, placebo-controlled clinical trials, 1126 patients with CKD on dialysis received study drug (656 cinacalcet, 470 placebo) for up to 6 months.

The most frequently reported adverse reactions are listed in Table 1. Seizures were observed in 1.4% (13/910) of cinacalcet-treated patients and 0.7% (5/641) of placebo-treated patients across all completed placebo-controlled trials. Table 1.

Adverse Reactions with Frequency ≥5% in Patients on Dialysis in Short-Term Studies for up to 6 Months * Included are events that were reported at a greater incidence in the cinacalcet group than in the placebo group. Event*: Placebo (n=470) (%) Cinacalcet (n=656) (%) Nausea Vomiting Diarrhea Myalgia Dizziness Hypertension Asthenia Anorexia Pain Chest, Non-Cardiac Dialysis Access Site Infection 19 15 20 14 8 5 4 4 4 4 31 27 21 15 10 7 7 6 6 5 In a randomized, double-blind placebo-controlled study of 3883 patients with secondary HPT and CKD receiving dialysis in which patients were treated for up to 64 months (mean duration of treatment was 21 months in the cinacalcet group), the most frequently reported adverse reactions (incidence of ≥ 5% in the cinacalcet group and a difference ≥ 1% compared to placebo) are listed in Table 2.

Table 2. Frequency of Adverse Reactions in Dialysis Patients Treated for up to 64 Months in a Long-Term Study 1 1 Adverse reactions that occurred in ≥ 5% frequency in the cinacalcet group and a difference ≥ 1% compared to the placebo group (Safety Analysis Set). Crude incidence rate = 100 * Total number of subjects with event/ n n=Number of subjects receiving at least one dose of study drug.

Placebo (n=1923) Cinacalcet (n=1938) 3699 subject-years 4044 subject-years Percent of subjects reporting Adverse Reactions (%) 90.9

93.2Nausea 15.5

29.1Vomiting 13.7

25.6Diarrhea 18.7

20.5Dyspnea 11.5

13.4Cough 9.8

11.7Hypotension 10.5

11.6Headache 9.6

11.5Hypocalcemia 1.4

11.2Muscle spasms 9.2

11.1Abdominal pain 9.6

10.9Abdominal pain upper 6.3

8.2Hyperkalemia 6.1

8.1Upper respiratory tract infection 6.3

7.6Dyspepsia 4.6

7.4Dizziness 4.7

7.3Decreased appetite 3.5

5.9Asthenia 3.8

5.4Constipation 3.8 5 Additional adverse reaction rates from the long-term, randomized, double-blind placebo-controlled study for cinacalcet versus placebo are as follows: seizure (2.5%, 1.6%), rash (2.2%, 1.9%), hypersensitivity reactions (9.4%, 8.3%). Patients with Parathyroid Carcinoma and Primary Hyperparathyroidism The safety profile of cinacalcet in these patient populations is generally consistent with that seen in patients with CKD on dialysis. Forty six patients were treated with cinacalcet in a single-arm study, 29 with Parathyroid Carcinoma and 17 with intractable pHPT.

Nine (20%) of the patients withdrew from the study due to adverse events. The most frequent adverse reactions and the most frequent cause of withdrawal in these patient populations were nausea and vomiting. Severe or prolonged cases of nausea…

🔄 Drug Interactions 156 words ▾

7 DRUG INTERACTIONS Co-administration with a strong CYP3A4 inhibitor may increase serum levels of cinacalcet. Dose adjustment and monitoring of iPTH serum phosphorus and serum calcium may be required. ( 7.1 ) Cinacalcet is a strong inhibitor of CYP2D6. Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6. ( 7.2 )

7.1Strong CYP3A4 Inhibitors Cinacalcet is partially metabolized by CYP3A4. Dose adjustment of cinacalcet may be required if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole). The iPTH and serum calcium concentrations should be closely monitored in these patients [see Clinical Pharmacology (12.3) ] .

7.2CYP2D6 Substrates Cinacalcet is a strong inhibitor of CYP2D6. Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6 (e.g., desipramine, metoprolol, and carvedilol) and particularly those with a narrow therapeutic index (e.g., flecainide and most tricyclic antidepressants) [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use: A fatal outcome was reported in a pediatric clinical trial patient with severe hypocalcemia. Cinacalcet is not indicated for use in pediatric patients. ( 8.4 )

8.1Pregnancy Risk Summary Limited case reports of cinacalcet use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. In animal reproduction studies, when female rats were exposed to cinacalcet during the period of organogenesis through to weaning at 2 to 3 times the systemic drug levels (based on AUC) at the maximum recommended human dose (MRHD) of 180 mg/day, peripartum and early postnatal pup loss and reduced pup body weight gain were observed in the presence of maternal hypocalcemia [see Data] .

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In pregnant female rats given oral gavage doses of 2, 25, 50 mg/kg/day cinacalcet during gestation, no teratogenicity was observed at doses up to 50 mg/kg/day (exposure 4 times those resulting with a human oral dose of 180 mg/day based on AUC comparison).

Decreased fetal body weights were observed at all doses (less than 1 to 4 times a human oral dose of 180 mg/day based on AUC comparison) in conjunction with maternal toxicity (decreased food consumption and body weight gain). In pregnant female rabbits given oral gavage doses of 2, 12, 25 mg/kg/day cinacalcet during gestation, no adverse fetal effects were observed (exposures less than with a human oral dose of 180 mg/day based on AUC comparisons). Reductions in maternal food consumption and body weight gain were seen at doses of 12 and 25 mg/kg/day.

Cinacalcet has been shown to cross the placental barrier in rabbits. In pregnant rats given oral gavage doses of 5, 15, 25 mg/kg/day cinacalcet during gestation through lactation, no adverse fetal or pup (post-weaning) effects were observed at 5 mg/kg/day (exposures less than with a human therapeutic dose of 180 mg/day based on AUC comparisons). Higher doses of 15 and 25 mg/kg/day cinacalcet (exposures 2 to 3 times a human oral dose of 180 mg/day based on AUC comparisons) were accompanied by maternal signs of hypocalcemia (periparturient mortality and early postnatal pup loss), and reductions in postnatal maternal and pup body weight gain.

8.2Lactation Risk Summary There are no data regarding the presence of cinacalcet in human milk or effects on the breastfed infant or on milk production. Studies in rats showed that cinacalcet was excreted in the milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cinacalcet and any potential adverse effects on the breastfed infant from cinacalcet or from the underlying maternal condition.

8.4Pediatric Use The safety and efficacy of cinacalcet have not been established in pediatric patients. The use of cinacalcet for the treatment of secondary HPT in pediatric patients with CKD on dialysis was evaluated in two randomized, controlled studies (Pediatric Study 1 and Study 2) where 47 pediatric patients aged 6 years to less than 18 years received at least one dose of cinacalcet and in one single-arm study (Pediatric Study 3) where 17 pediatric patients aged 28 days to less than 6 years received at least one dose of cinacalcet.

Dosing with cinacalcet in Pediatric Study 1 was stopped because of a fatality in a cinacalcet-treated individual. The individual was noted to be severely hypocalcemic at the time of death. The cause of death was multifactorial and a contribution of cinacalcet to the death could not be excluded [see Warnings and Precautions (5.1) ].

Study 1 was terminated and changes to cinacalcet dosing after the fatality were implemented in Pediatric Study 2 and Study 3 to…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Limited case reports of cinacalcet use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. In animal reproduction studies, when female rats were exposed to cinacalcet during the period of organogenesis through to weaning at 2 to 3 times the systemic drug levels (based on AUC) at the maximum recommended human dose (MRHD) of 180 mg/day, peripartum and early postnatal pup loss and reduced pup body weight gain were observed in the presence of maternal hypocalcemia [see Data] .

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In pregnant female rats given oral gavage doses of 2, 25, 50 mg/kg/day cinacalcet during gestation, no teratogenicity was observed at doses up to 50 mg/kg/day (exposure 4 times those resulting with a human oral dose of 180 mg/day based on AUC comparison).

Decreased fetal body weights were observed at all doses (less than 1 to 4 times a human oral dose of 180 mg/day based on AUC comparison) in conjunction with maternal toxicity (decreased food consumption and body weight gain). In pregnant female rabbits given oral gavage doses of 2, 12, 25 mg/kg/day cinacalcet during gestation, no adverse fetal effects were observed (exposures less than with a human oral dose of 180 mg/day based on AUC comparisons). Reductions in maternal food consumption and body weight gain were seen at doses of 12 and 25 mg/kg/day.

Cinacalcet has been shown to cross the placental barrier in rabbits. In pregnant rats given oral gavage doses of 5, 15, 25 mg/kg/day cinacalcet during gestation through lactation, no adverse fetal or pup (post-weaning) effects were observed at 5 mg/kg/day (exposures less than with a human therapeutic dose of 180 mg/day based on AUC comparisons). Higher doses of 15 and 25 mg/kg/day cinacalcet (exposures 2 to 3 times a human oral dose of 180 mg/day based on AUC comparisons) were accompanied by maternal signs of hypocalcemia (periparturient mortality and early postnatal pup loss), and reductions in postnatal maternal and pup body weight gain.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and efficacy of cinacalcet have not been established in pediatric patients. The use of cinacalcet for the treatment of secondary HPT in pediatric patients with CKD on dialysis was evaluated in two randomized, controlled studies (Pediatric Study 1 and Study 2) where 47 pediatric patients aged 6 years to less than 18 years received at least one dose of cinacalcet and in one single-arm study (Pediatric Study 3) where 17 pediatric patients aged 28 days to less than 6 years received at least one dose of cinacalcet.

Dosing with cinacalcet in Pediatric Study 1 was stopped because of a fatality in a cinacalcet-treated individual. The individual was noted to be severely hypocalcemic at the time of death. The cause of death was multifactorial and a contribution of cinacalcet to the death could not be excluded [see Warnings and Precautions (5.1) ].

Study 1 was terminated and changes to cinacalcet dosing after the fatality were implemented in Pediatric Study 2 and Study 3 to minimize the risk of severe hypocalcemia. The data in Pediatric Studies 2 and 3 were insufficient to establish the safety and efficacy of cinacalcet for the treatment of secondary HPT in pediatric patients with CKD on dialysis. In aggregate, the pediatric studies did not establish a safe and effective cinacalcet dosing regimen for the pediatric population.

🧓 Geriatric Use 84 words ▾

8.5Geriatric Use Of the total number of subjects (n = 1136) in clinical studies of cinacalcet, 26 percent were 65 and over, and 9 percent were 75 and over. No overall differences in the safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Studies (14) and Clinical Pharmacology (12.3) ] .

🆘 Overdosage 56 words ▾

10 OVERDOSAGE Overdosage of cinacalcet may lead to hypocalcemia. In the event of overdosage, patients should be monitored for signs and symptoms of hypocalcemia and appropriate measures taken to correct serum calcium levels [see Warnings and Precautions (5.1) ] . Since cinacalcet is highly protein bound, hemodialysis is not an effective treatment for overdosage of cinacalcet.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The calcium-sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH synthesis and secretion. Cinacalcet, the active ingredient in cinacalcet tablets, is a calcimimetic agent that directly lowers PTH levels by increasing the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. The reduction in PTH is associated with a concomitant decrease in serum calcium levels.

12.2Pharmacodynamics Reduction in iPTH levels correlated with the plasma cinacalcet concentrations in patients with CKD. The nadir in iPTH level occurs approximately 2 to 6 hours post dose, corresponding with the maximum plasma concentration (C max ) of cinacalcet. After steady-state cinacalcet concentrations are reached (which occurs within 7 days of dose change), serum calcium concentrations remain constant over the dosing interval in patients with CKD.

Reductions in PTH are associated with a decrease in bone turnover and bone fibrosis in patients with CKD on dialysis and uncontrolled secondary HPT.

12.3Pharmacokinetics Absorption and Distribution After oral administration of cinacalcet, C max is achieved in approximately 2 to 6 hours. Cinacalcet C max and AUC (0-infinite) were increased by 82% and 68%, respectively, following administration with a high-fat meal compared with fasting in healthy volunteers. The C max and AUC (0-infinite) of cinacalcet were increased by 65% and 50%, respectively, when cinacalcet was administered with a low-fat meal compared with fasting.

After absorption, cinacalcet concentrations decline in a biphasic fashion with an initial half-life of approximately 6 hours and terminal half-life of 30 to 40 hours. Steady-state drug levels are achieved within 7 days, and the mean accumulation ratio is approximately 2 with once daily oral administration. The median accumulation ratio is approximately 2 to 5 with twice daily oral administration.

The AUC and C max of cinacalcet increase proportionally over the dose range of 30 to 180 mg once daily. The pharmacokinetic profile of cinacalcet does not change over time with once daily dosing of 30 to 180 mg. The volume of distribution is approximately 1000 L, indicating extensive distribution.

Cinacalcet is approximately 93% to 97% bound to plasma protein(s). The ratio of blood cinacalcet concentration to plasma cinacalcet concentration is 0.8 at a blood cinacalcet concentration of 10 ng/mL. Metabolism and Excretion Cinacalcet is metabolized by multiple enzymes, primarily CYP3A4, CYP2D6, and CYP1A2.

After administration of a 75 mg radiolabeled dose to healthy volunteers, cinacalcet was metabolized via: 1) oxidative N-dealkylation to hydrocinnamic acid and hydroxy-hydrocinnamic acid, which are further metabolized via β-oxidation and glycine conjugation; the oxidative N-dealkylation process also generates metabolites that contain the naphthalene ring; and 2) oxidation of the naphthalene ring on the parent drug forming dihydrodiols, which are further conjugated with glucuronic acid. The plasma concentrations of the major circulating metabolites, including the cinnamic acid derivatives and glucuronidated dihydrodiols, markedly exceed the parent drug concentrations.

The hydrocinnamic acid metabolite and glucuronide conjugates have minimal or no calcimimetic activity. Renal excretion of metabolites was the primary route of elimination of radioactivity. Approximately 80% of the dose was recovered in the urine and 15% in the feces.

Specific Populations Age: Geriatric Population The pharmacokinetic profile of cinacalcet in geriatric patients (age ≥ 65 years, n = 12) is similar to that for patients who are < 65 years of age (n = 268) [see Use in Specific Populations (8.5) ] . Hepatic Impairment The disposition of a 50 mg cinacalcet single dose was compared between patients with hepatic impairment and patients with normal hepatic function. Cinacalcet exposure (AUC (0-infinite) ) was…

🧬 Mechanism of Action 70 words ▾

12.1Mechanism of Action The calcium-sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH synthesis and secretion. Cinacalcet, the active ingredient in cinacalcet tablets, is a calcimimetic agent that directly lowers PTH levels by increasing the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. The reduction in PTH is associated with a concomitant decrease in serum calcium levels.

📦 How Supplied / Storage and Handling 150 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Cinacalcet Tablets, 30 mg are light green, film-coated, oval shaped, biconvex tablets debossed with “80” on one side and “Y” on the other side. Bottles of 30 NDC 84386-111-30 Bottles of 90 NDC 84386-111-90 Bottles of 100 NDC 84386-111-01 Bottles of 500 NDC 84386-111-05 Cinacalcet Tablets, 60 mg are light green, film-coated, oval shaped, biconvex tablets debossed with “81” on one side and “Y” on the other side. Bottles of 30 NDC 84386-112-30 Bottles of 90 NDC 84386-112-90 Bottles of 100 NDC 84386-112-01 Bottles of 500 NDC 84386-112-05 Cinacalcet Tablets, 90 mg are light green, film-coated, oval shaped, biconvex tablets debossed with “82” on one side and “Y” on other side.

Bottles of 30 NDC 84386-113-30 Bottles of 90 NDC 84386-113-90 Bottles of 100 NDC 84386-113-01 Bottles of 500 NDC 84386-113-05 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 203 words ▾

11 DESCRIPTION Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C 22 H 22 F 3 N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration.

The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively).

Inactive Ingredients The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin. Chemical Structure

💬 Information for Patients 187 words ▾

17 PATIENT COUNSELING INFORMATION Hypocalcemia: Advise patients to report symptoms of hypocalcemia, including paresthesias, myalgias, muscle spasms, and seizures, to their healthcare provider [see Warnings and Precautions (5.1) ]. Upper Gastrointestinal Bleeding: Advise patients to report any symptoms of upper gastrointestinal bleeding to their health care provider [see Warnings and Precautions (5.2) ]. Heart Failure: Advise patients with heart failure that use of cinacalcet may worsen their heart failure and additional monitoring may be required [see Warnings and Precautions (5.3) ].

Advise patients to report nausea and vomiting to their health care provider [see Adverse Reactions (6.1) ]. Advise patients to take cinacalcet with food or shortly after a meal and to take the tablets whole and not divide them [see Dosage and Administration (2.1) ] . Inform patients of the importance of regular blood tests, in order to monitor the safety and efficacy of cinacalcet therapy.

The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 09/2025

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

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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.
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Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (84386-0111-30), 90 tablets (84386-0111-90), 100 tablets (84386-0111-01). Each has its own NDC and its own page — see the package list near the top of this page.
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