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Calcium Acetate 667 mg Capsule, 200-count — NDC 16571-813-20 (Billing 16571-0813-20)

by Rising Pharma Holdings, Inc. · 200 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 200 capsules of Calcium Acetate 667 mg Capsule from Rising Pharma Holdings, Inc., marketed since Nov 2021 and currently FDA-listed; retail pharmacies pay about $0.1697 per capsule (NADAC). It is this product's only package size.

NDC 16571-0813-20
🏷️ FDA NDC (as labeled) 16571-813-20 billing pads the product segment with a zero
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 16571-813-20
Product NDC 16571-813
11-digit billing NDC 16571081320
NCPDP billing unit EA — each (per item)
RxCUI 359296
UNII Y882YXF34X
Application # ANDA211038
SPL Set ID ce650ba5-fb42-e444-e053-2a95a90a075a
Established class (EPC) Blood Coagulation Factor; Cations; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Physiologic effect Increased Coagulation Factor Activity
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-11-01
Route ORAL
Dosage form CAPSULE
Substance CALCIUM ACETATE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 52800020100120
GPI class Calcium Acetate (Phos Binder)
GCN Seq No 048241
GCN 13675
HICL code 004884
Ingredient (HICL) Calcium Acetate
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1A
Therapeutic class — specific (HIC3) Electrolyte Depleters
AHFS code 40:18.19.00
AHFS class Phosphate-Removing Agents
FDB label name CALCIUM ACETATE 667 MG CAPSULE
FDB brand name Calcium Acetate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048241
  • GCN: 13675
  • GPI-14 (Medi-Span): 52800020100120
  • HICL (First Databank): 004884
  • AHFS class code: 40:18.19.00
  • RxCUI (RxNorm): 359296
Why two NDCs? The FDA registers this code as 16571-813-20 — 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 → 16571-0813-20. 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 Drugs for treatment of hyperkalemia and hyperphosphatemia class.

Drug family (ATC) Drugs for treatment of hyperkalemia and hyperphosphatemia
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 CALCIUM ACETATE 667 MG CAPSULE Ingredient Calcium Acetate
📗 Our plain-language guide HelloPharmacist
  • It lowers the phosphorus in your blood if you have end stage renal disease. Failing kidneys can't clear phosphorus well, so it builds up. Calcium acetate helps by binding phosphate...
  • Take it by mouth with each meal. It needs to be in your stomach with your food to bind the phosphate. Your prescriber will adjust how many you take based on your blood tests, so fo...
  • The most common are high blood calcium, nausea and vomiting. Some people also report dizziness, swelling or weakness. Call your doctor if you have ongoing nausea, constipation, poo...
  • Avoid them unless your doctor says otherwise. Calcium supplements and calcium-based antacids add more calcium and raise the risk of high blood calcium. Check with me before taking...
📖 Read our full Calcium Acetate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eaPer package
Retail pharmacies payNADAC · weekly $0.170 $33.94 / 200 capsules
Medicaid paysCMS SDUD · 12 mo $0.5506 $110.12 / 200 capsules
Medicare drug plans payPart D · Q2 2026 $0.2616 $52.32 / 200 capsules
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.335 $0.167
▼ Down 44% over the last 24 months.
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
16571-0813-20 You're viewing this Main listing 200 CAPSULE in 1 BOTTLE, PLASTIC 2021-11-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calcium Acetate 667 mg 00054-0088-13 Hikma 30 capsules $0.170 AB Availability likely —
Calcium Acetate 667 mg 00904-7119-06 Major 50 capsules $0.170 AB Availability likely —
Calcium Acetate 667 mgthis 16571-0813-20 Rising 200 capsules $0.170 AB Availability likely —
calcium acetate 667 mg 23155-0531-02 Heritage 200 capsules $0.170 AB Availability likely —
Calcium Acetate 667 mg 62135-0191-22 Chartwell 200 capsules $0.170 AB Availability likely —
Calcium Acetate 667 mg 68084-0479-01 American 100 capsules $0.170 AB Availability likely —
Calcium Acetate 667 mg 69367-0411-02 Westminster 200 capsules $0.170 AB Availability likely —
Calcium Acetate 667 mg 75834-0323-02 Nivagen 200 capsules $0.170 AB Availability likely —
Calcium Acetate 667 mg 76282-0377-02 EXELAN 200 capsules $0.170 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 —
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

🏛️
2021
On the market since
Nov 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
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 blue / white
ShapeCapsule
ImprintSuven;667
Size22 mm
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerRising Pharma Holdings, Inc.
Application holderSUVEN PHARMACEUTICALS LTD
FDA applicationANDA211038 (ANDA)
Labeler code16571
First marketedNov 2021
Product typeHuman Prescription Drug
Portfolio525 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. 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

1 INDICATIONS AND USAGE Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).

⏱️ Dosage and Administration 53 words ▾

2 DOSAGE AND ADMINISTRATION The recommended initial dose of calcium acetate capsules 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.

💊 Dosage Forms and Strengths 13 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsule: 667 mg calcium acetate, USP per capsule.

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS Patients with hypercalcemia.

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS

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 mg2/dL2.

5.2Concomitant Use with Medications Hypercalcemia may aggravate digitalis toxicity.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Hypercalcemia is discussed elsewhere [ see Warnings and Precautions (5.1) ]

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-mo, 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.

6.2Post marketing 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 postapproval of calcium acetate: dizziness, edema, and weakness.

🔄 Drug Interactions 168 words ▾

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.

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 ~1 min read ▾

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 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.

🆘 Overdosage 24 words ▾

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 114 words ▾

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 non-fasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.

📦 How Supplied / Storage and Handling 86 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Calcium Acetate capsules USP, 667 mg are hard gelatin capsules with blue opaque cap imprinted with “SUVEN” in white color ink and a white opaque body imprinted with “667” blue color ink. Each capsule contains 667 mg calcium acetate (anhydrous Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. NDC 16571-813-20 Bottles of 200 with child-resistant closure.

STORAGE Store at 20°-25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

📦 Storage and Handling 19 words ▾

STORAGE Store at 20°-25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

📋 Description 169 words ▾

11 DESCRIPTION Calcium acetate, USP acts as a phosphate binder. Its chemical name is Calcium acetate, USP. Its molecular formula is C 4 H 6 CaO 4 , and its molecular weight is 158.17.

Its structural formula is: Each opaque capsule with a blue cap and white body is spin printed in blue and white ink with “SUVEN” printed on the cap and “667” printed on the body. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, and water as the inert binder, crospovidone and sodium stearyl fumarate . The gelatin cap and body have the following inactive ingredients: FD&C blue 1, D&C red 28, titanium dioxide and gelatin.

Imprinting ink on capsule body contains shellac and FD&C 2 Aluminum Lake and imprinting ink on capsule cap contains shellac, titanium dioxide and potassium hydroxide. Calcium acetate capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure. Meets USP Dissolution Test 4 Structure

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Effectiveness of calcium acetate in decreasing serum phosphorus has been demonstrated in two studies of the calcium acetate solid oral dosage form. Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1-week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study. The patients received calcium acetate 667 mg tablets at each meal for a period of 12 weeks.

The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.

The data presented in Table 2 demonstrate the efficacy of calcium acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum calcium levels are also presented. Table 2: Average Serum Phosphorous and Calcium Levels at Pre-Study, Interim, and Study Completion Time points Parameter Pre-Study Week 4 b Week 8 Week 12 p-value c Phosphorous (mg/dL) a 7.4 ± 0.17 5.9 ± 0.16 5.6 ± 0.17 5.2 ± 0.17 ≤0.01 Calcium 8.9 ± 0.09 9.5 ± 0.10 9.7 ± 0.10 9.7 ± 0.10 ≤0.01 a Values expressed as mean ± SE. b Ninety-one patients completed at least 6 weeks of the study. c ANOVA of difference in values at pre-study and study completion.

There was a 30% decrease in serum phosphorus levels during the 12-week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum calcium increased 9% during the study mostly in the first month of the study.

Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive calcium acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.

The phosphate binding effect of calcium acetate is shown in the Table 3. Table 3: Serum Phosphorous and Calcium Levels at Study Initiation and After Completion of Each Treatment Arm Parameter Pre-Study Post Treatment p-value b Calcium Acetate Placebo Phosphorous (mg/dL) a 7.3 ± 0.18 5.9 ± 0.24 7.8 ± 0.22 <0.01 Calcium (mg/dL)a 8.9 ± 0.11 9.5 ± 0.13 8.8 ± 0.12 <0.01 a Values expressed as mean ± SEM b ANOVA of calcium acetate vs. placebo after 2 weeks of treatment. Overall, 2 weeks of treatment with calcium acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum calcium by a statistically significant (p<0.01) but clinically unimportant mean of 7%.

🧪 Nonclinical Toxicology 21 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, mutagenicity, or fertility studies have been conducted with calcium acetate.

📄 Patient Package Insert ~2 min read ▾

These highlights do not include all the information needed to use CALCIUM ACETATE CAPSULES safely and effectively. Please see full prescribing information for CALCIUM ACETATE CAPSULES. CALCIUM ACETATE capsules, for oral use Initial U.S.

Approval: 1990 These highlights do not include all the information needed to use CALCIUM ACETATE CAPSULES safely and effectively. See full prescribing information for CALCIUM ACETATE CAPSULES. CALCIUM ACETATE capsules, for oral use Initial U.S.

Approval: 1990 --------------------INDICATIONS AND USAGE--------------- Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.(1) ---------------DOSAGE AND ADMINISTRATION----------- 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-------- Capsule: 667 mg calcium acetate capsule.(3) --------------------CONTRAINDICATIONS--------------------- Hypercalcemia.(4) ------------------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) -------------------------ADVERSE REACTIONS-------------------- 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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch --------------DRUG INTERACTIONS--------------------- 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) See 17 for PATIENT COUNSELING INFORMATION Revised: 01/2026 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS

5.1 Hypercalcemia

5.2 Concomitant Use with Medications 6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post marketing Experience 7 DRUG INTERACTIONS

7.1 Ciprofloxacin 8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Labor and Delivery

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics 13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 15 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed 1 INDICATIONS AND USAGE Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). 2 DOSAGE AND ADMINISTRATION The recommended initial dose of calcium acetate capsules 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. 3 DOSAGE FORMS AND STRENGTHS Capsule: 667 mg calcium acetate, USP per capsule.

4 CONTRAINDICATIONS Patients with hypercalcemia. 5 WARNINGS AND PRECAUTIONS

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 req… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 17 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Calcium Acetate Capsules USP NDC 16571-813-20 667 mg 200 Capsules Rx only Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
35.6K
Units reimbursed last 4 qtrs
5.5M
Gross reimbursed last 4 qtrs
$3.01M
Avg / prescription
$84.56
Avg / unit
$0.5506
Latest quarter Q1 2026
6.4KRx
Medicaid pays / ea
$0.5506
gross reimbursed
vs
NADAC / ea
$0.1697
acquisition cost
=
Spread
+$0.3809
+224% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
31% FFS 69% MCO
Fee-for-service · 11,015 Rx Managed care · 24,536 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 103,136 units · 1,320 per 100k residents WA Idaho: 7,772 units · 396 per 100k residents ID Montana: 12,085 units · 1,068 per 100k residents MT North Dakota: 7,084 units · 905 per 100k residents ND Minnesota: 158,209 units · 2,758 per 100k residents MN Wisconsin: 44,526 units · 753 per 100k residents WI Michigan: 119,277 units · 1,188 per 100k residents MI New York: 461,515 units · 2,358 per 100k residents NY Vermont: no data reported VT New Hampshire: 2,606 units · 186 per 100k residents NH Oregon: 186,167 units · 4,398 per 100k residents OR Nevada: 43,033 units · 1,347 per 100k residents NV Wyoming: no data reported WY South Dakota: 30,104 units · 3,276 per 100k residents SD Iowa: 30,023 units · 936 per 100k residents IA Illinois: 128,693 units · 1,026 per 100k residents IL Indiana: 91,720 units · 1,337 per 100k residents IN Ohio: 492,214 units · 4,177 per 100k residents OH Pennsylvania: 394,791 units · 3,046 per 100k residents PA New Jersey: 58,126 units · 626 per 100k residents NJ Massachusetts: 26,395 units · 377 per 100k residents MA California: 1,423,213 units · 3,653 per 100k residents CA Utah: 10,843 units · 317 per 100k residents UT Colorado: 49,122 units · 836 per 100k residents CO Nebraska: no data reported NE Missouri: 89,371 units · 1,442 per 100k residents MO Kentucky: 121,625 units · 2,687 per 100k residents KY West Virginia: 16,456 units · 930 per 100k residents WV Virginia: 116,871 units · 1,341 per 100k residents VA Maryland: 83,745 units · 1,355 per 100k residents MD Connecticut: 139,282 units · 3,851 per 100k residents CT Rhode Island: 7,626 units · 696 per 100k residents RI Arizona: 158,490 units · 2,133 per 100k residents AZ New Mexico: 50,756 units · 2,401 per 100k residents NM Kansas: 27,847 units · 947 per 100k residents KS Arkansas: 37,428 units · 1,220 per 100k residents AR Tennessee: 63,392 units · 890 per 100k residents TN North Carolina: 112,745 units · 1,041 per 100k residents NC South Carolina: 26,993 units · 502 per 100k residents SC Delaware: 18,582 units · 1,802 per 100k residents DE Oklahoma: 43,507 units · 1,073 per 100k residents OK Louisiana: 31,918 units · 698 per 100k residents LA Mississippi: 60,057 units · 2,043 per 100k residents MS Alabama: 12,794 units · 250 per 100k residents AL Georgia: 71,300 units · 646 per 100k residents GA D.C.: 15,406 units · 2,269 per 100k residents DC Hawaii: 64,542 units · 4,498 per 100k residents HI Texas: 48,593 units · 159 per 100k residents TX Florida: 36,792 units · 163 per 100k residents FL
Units reimbursed · per 100k residents
1594,498
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Hawaii 4,498 /100k
2 Oregon 4,398 /100k
3 Ohio 4,177 /100k
4 Connecticut 3,851 /100k
5 California 3,653 /100k
6 South Dakota 3,276 /100k
7 Pennsylvania 3,046 /100k
8 Minnesota 2,758 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Calcium Acetate — the program that covers self-administered drugs. 8 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 Calcium Acetate. 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
$337.8K
Claims incl. refills
6K
Beneficiaries
3.8K
Spend / beneficiary
$87.82
Spend / claim
$56.02
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Calcium Acetate — the ingredient across all brands.

Top reported reactions

Renal Failure489
Chronic Kidney Disease467
End Stage Renal Disease437
Acute Kidney Injury380
Diarrhoea335
Nausea270
Fatigue259

Age at onset

Neonate6
Infant2
Child1
Adolescent2
Adult393
Elderly336

Reporter sex

5,422 reports
Male · 48%
Female · 52%
Unknown · 0%

Serious outcomes

Hospitalization2,291
Life-threatening250
Disabling152
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 329 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 16571-0812-05 · Rising 16571-0814-50 · Rising →
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.