Calcium Acetate 667 mg Capsule, 100-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Drugs for treatment of hyperkalemia and hyperphosphatemia class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Calcium acetate is used to control high blood levels of phosphorus in people with kidney disease who are on dialysis (medical treatment to clean the blood when the kidneys are not working properly). Calcium acetate is in a class of medications called phosphate binders. It binds phosphorus that you get from foods in your diet and prevents it from being absorbed into your blood stream.
Read the full MedlinePlus article ↗- It's a fair question. Calcium acetate isn't being used here to boost your calcium — it's being used as a phosphate binder. When you take it with a meal, it grabs onto phosphate fro...
- What is calcium acetate actually doing for me — isn't calcium a normal supplement?
- Yes, timing with food is everything. You need to take it with each meal — not before, not hours after. The whole point is for it to be in your gut at the same time as the phosphate...
- When exactly should I take it — does it matter if I take it with food?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
-
UNII 8PJ61P6TS3
Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
-
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
-
UNII PN2ZH5LOQY
A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
-
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
-
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
-
UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
-
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.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.167 | $16.69 / 100 capsule |
| Medicaid paysCMS SDUD · 12 mo | $0.4736 | $47.36 / 100 capsule |
| Medicare drug plans payPart D · Q2 2026 | $0.2616 | $26.16 / 100 capsule |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Calcium Acetate 667 mg 00054-0088-13 | Hikma | 30 capsules | $0.167 | AB | Availability likely | — |
| Calcium Acetate 667 mgthis 00904-7119-61 | Major | 100 capsules | $0.167 | AB | Availability likely | — |
| Calcium Acetate 667 mg 16571-0813-20 | Rising | 200 capsules | $0.167 | AB | Availability likely | — |
| calcium acetate 667 mg 23155-0531-02 | Heritage | 200 capsules | $0.167 | AB | Availability likely | — |
| Calcium Acetate 667 mg 62135-0191-22 | Chartwell | 200 capsules | $0.167 | AB | Availability likely | — |
| Calcium Acetate 667 mg 68084-0479-01 | American | 100 capsules | $0.167 | AB | Availability likely | — |
| Calcium Acetate 667 mg 69367-0411-02 | Westminster | 200 capsules | $0.167 | AB | Availability likely | — |
| Calcium Acetate 667 mg 75834-0323-02 | Nivagen | 200 capsules | $0.167 | AB | Availability likely | — |
| Calcium Acetate 667 mg 76282-0377-02 | EXELAN | 200 capsules | $0.167 | AB | Availability likely | — |
| Calcium Acetate 667 mg 00615-8632-39 | NCS | 30 capsules | — | AB | FDA listed | — |
| Calcium Acetate 667 mg 50268-0203-15 | AvPAK | 50 capsules | — | AB | FDA listed | — |
| Calcium Acetate 667 mg 53746-0590-01 | Amneal | 100 capsules | — | — | FDA listed | — |
| Calcium Acetate 667 mg 55154-4169-00 | Cardinal | 10 capsules | — | AB | FDA listed | — |
| Calcium Acetate 667 mg 60429-0491-02 | Golden | 200 capsules | — | AB | Discontinued | — |
| Calcium Acetate 667 mg 69097-0862-03 | Cipla | 60 capsules | — | AB | FDA listed | — |
| calcium acetate 667 mg 70518-4299-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Calcium Acetate 667 mg 72789-0422-97 | PD-Rx | 200 capsules | — | AB | FDA listed | — |
| calcium acetate 667 mg 73190-0031-20 | AvKARE | 200 capsules | — | AB | FDA listed | — |
| Calcium Acetate 667 mg 76483-0086-00 | SQUARE | 200 capsules | — | AB | FDA listed | — |
| Calcium Acetate 667 mg 82804-0968-00 | Proficient | 100 capsules | — | AB | FDA listed | — |
| Calcium Acetate 667 mg 60687-0589-01 | American | 100 capsules | — | AB | Discontinued | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00904-7119-06 | 50 BLISTER PACK in 1 CARTON (0904-7119-06) / 1 CAPSULE in 1 BLISTER PACK | $0.1669 / ea | $8.35 | 2008-02-26 | Active |
| 00904-7119-61 You're viewing this | 100 BLISTER PACK in 1 CARTON (0904-7119-61) / 1 CAPSULE in 1 BLISTER PACK | $0.1669 / ea | $16.69 | 2008-02-26 | Active |
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.1669 NADAC).
Pack size FAQ
What quantity is in NDC 00904-7119-61?
What is the difference between NDC 00904-7119-61 and NDC 00904-7119-06?
What NDC number is used to bill for this package of Calcium Acetate 667 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). • Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended initial dose of calcium acetate for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal. • Starting dose is 2 capsules with each meal.
( 2 ) • Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 capsules with each meal. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Capsule: 667 mg calcium acetate capsule. • Capsule: 667 mg calcium acetate capsule. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Patients with hypercalcemia. • Hypercalcemia. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Treat mild hypercalcemia by reducing or interrupting calcium acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate. ( 5.1 ) • Hypercalcemia may aggravate digitalis toxicity. ( 5.2 )
5.1Hypercalcemia Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate. Avoid the use of calcium supplements, including calcium based nonprescription antacids, concurrently with calcium acetate. An overdose of calcium acetate may lead to progressive hypercalcemia, which may require emergency measures.
Therefore, early in the treatment phase during the dosage adjustment period, monitor serum calcium levels twice weekly. Should hypercalcemia develop, reduce the calcium acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia. More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma.
Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy. Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the calcium acetate dose or temporarily discontinuing therapy.
Decreasing or discontinuing Vitamin D therapy is recommended as well. Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification.
The long term effect of calcium acetate on the progression of vascular or soft tissue calcification has not been determined. Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3 month study of solid dose formulation of calcium acetate; all cases resolved upon lowering the dose or discontinuing treatment. Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg 2 /dL 2 .
5.2Concomitant Use with Medications Hypercalcemia may aggravate digitalis toxicity.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1) ]. • The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. ( 6.1 ) • In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trial 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, calcium acetate has been generally well tolerated. Calcium acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of calcium acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients.
Adverse reactions (>2% on treatment) from these trials are presented in Table 1. Table 1: Adverse Reactions in Patients with End-Stage Renal Disease Undergoing Hemodialysis Preferred Term Total adverse reactions reported for calcium acetate N=167 N (%) 3 month, open label study of calcium acetate N=98 N (%) Double blind, placebo-controlled, cross-over study of liquid calcium acetate N=69 Calcium acetate N (%) Placebo N (%) Nausea 6 (3.6) 6 (6.1) 0 (0.0) 0 (0.0) Vomiting 4 (2.4) 4 (4.1) 0 (0.0) 0 (0.0) Hypercalcemia 21 (12.6) 16 (16.3) 5 (7.2) 0 (0.0) Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting.
More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate - induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.
6.2Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure. The following additional adverse reactions have been identified during post-approval of calcium acetate: dizziness, edema, and weakness.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS The drug interaction of calcium acetate is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism. There are no empirical data on avoiding drug interactions between calcium acetate and most concomitant drugs.
When administering an oral medication with calcium acetate where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after calcium acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of calcium acetate. • Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones.
( 7 ) • When clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after calcium acetate or consider monitoring blood levels of the drug. ( 7 )
7.1Ciprofloxacin In a study of 15 healthy subjects, a co-administered single dose of 4 calcium acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Category C: Calcium acetate capsules contains calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions ( 5.1 )] .
Maintenance of normal serum calcium levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.
8.2Labor and Delivery The effects of calcium acetate on labor and delivery are unknown.
8.3Nursing Mothers Calcium acetate capsules contains calcium acetate and is excreted in human milk. Human milk feeding by a mother receiving calcium acetate is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Clinical studies of calcium acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses between 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.
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C: Calcium acetate capsules contains calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions ( 5.1 )] .
Maintenance of normal serum calcium levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of calcium acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses between 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 ▾
10 OVERDOSAGE Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1) ].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.
12.1Mechanism of Action Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
12.2Pharmacodynamics Orally administered calcium acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Calcium Acetate Capsules, USP 667 mg capsule is supplied as a white opaque/blue opaque capsule, imprinted with “54 215” on the cap and body. Cartons of 50 capsules (10 capsules each blister pack x 5), NDC 0904-7119-06 Cartons of 100 capsules (10 capsules each blister pack x 10), NDC 0904-7119-61 WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
📋 Description ▾
11 DESCRIPTION Calcium acetate acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C 4 H 6 CaO 4 , and its molecular weight is 158.17.
Its structural formula is: Each white opaque/blue opaque capsule contains 667 mg of calcium acetate, USP (anhydrous; Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.
Calcium Acetate Capsules, USP are administered orally for the control of hyperphosphatemia in end-stage renal failure. chem.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Inform patients to take calcium acetate capsules with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after calcium acetate capsules.
Distr. by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number C50000408/01 Revised September 2020