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Calcium Acetate 667 mg Capsule, 200-count — NDC 69367-411-02 (Billing 69367-0411-02)

by Westminster Pharmaceuticals, LLC · 200 CAPSULE in 1 BOTTLE

This is a package of 200 capsules of Calcium Acetate 667 mg Capsule from Westminster Pharmaceuticals, LLC, marketed since Jun 2025 and currently FDA-listed; retail pharmacies pay about $0.1697 per capsule (NADAC). It is this product's only package size.

NDC 69367-0411-02
🏷️ FDA NDC (as labeled) 69367-411-02 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

NDC database record

One package, one record: these facts belong to NDC 69367-411-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69367 labeler · 411 product · 02 package
Package marketed since
Jun 13, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
200 EA per package
Barcode (UPC)
0369367411028
Medicaid fills, this package
582 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69367-411-02
Product NDC 69367-411
11-digit billing NDC 69367041102
NCPDP billing unit EA — each (per item)
RxCUI 359296
UNII Y882YXF34X
UPC 0369367411028
Application # ANDA203179
SPL Set ID 1195f5d5-db91-4b9e-86ad-be340b43d690
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 2025-06-13
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
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 69367-411-02 — 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 → 69367-0411-02. 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 $0.2699 $53.98 / 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
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.182 $0.167
▼ Down 4% over the last 10 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
69367-0411-02 You're viewing this Main listing 200 CAPSULE in 1 BOTTLE 2025-06-13 — 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 mg 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 mgthis 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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.

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

LabelerWestminster Pharmaceuticals, LLC
Application holderMPP PHARMA LLC
FDA applicationANDA203179 (ANDA)
Labeler code69367
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio186 products on file

More NDCs from Westminster Pharmaceuticals, LLC labeler code 69367

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 📦 Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 48 words ▾

1. INDICATIONS & USAGE Calcium acetate capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate capsules are a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 )

⏱️ Dosage and Administration 86 words ▾

2. DOSAGE & 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 3-4 capsules with each meal. Starting dose is 2 capsules with each meal. ( 2 ) Titrate the dose every 2-3 weeks until acceptable serum phosphorus level is reached.

Most patients require 3-4 capsules with each meal. ( 2 )

💊 Dosage Forms and Strengths 21 words ▾

3. DOSAGE FORMS & STRENGTHS Capsule: 667 mg calcium acetate, USP per capsule. Capsule: 667 mg calcium acetate ( 3 )

⛔ Contraindications 9 words ▾

4. CONTRAINDICATIONS Patients with hypercalcemia. Hypercalcemia. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5. WARNINGS AND PRECAUTIONS Treat mild hypercalcemia by reducing or interrupting calcium acetate capsules and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate capsules. ( 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 (calcium acetate capsules). Avoid the use of calcium supplements, including calcium-based nonprescription antacids, concurrently with calcium acetate capsules. An overdose of calcium acetate capsules 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 capsules 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 capsules 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 capsules 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 capsules 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 × P) product below 55 mg2/dL2.

5.2Concomitant Use with Medications Hypercalcemia may aggravate digitalis toxicity.

🤒 Adverse Reactions ~2 min read ▾

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 Westminster Pharmaceuticals, LLC. at 1-844-221-7294 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 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 capsules were studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and in a two week double-blind, placebo-controlled, crossover 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 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 capsules induced hypercalcemia. Isolated cases of 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 ~1 min read ▾

7. DRUG INTERACTIONS The drug interaction of calcium acetate capsules is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl and hydroxyl groups). Calcium acetate capsules may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.

There are no empirical data on avoiding drug interactions between calcium acetate or calcium acetate capsules and most concomitant drugs. When administering an oral medication with calcium acetate capsules 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 capsules or 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 capsules 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 capsules, 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 2.7 g 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 contain calcium acetate. Animal reproduction studies have not been conducted with calcium acetate capsules, and there are no adequate and well controlled studies of calcium acetate capsules 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 capsules treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.

8.2LABOR & DELIVERY The effects of calcium acetate capsules on labor and delivery are unknown.

8.3NURSING MOTHERS Calcium acetate capsules contain calcium acetate and is excreted in human milk. Human milk feeding by a mother receiving calcium acetate capsules 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 the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🤰 Pregnancy 118 words ▾

8.1PREGNANCY Pregnancy Category C Calcium acetate capsules contain calcium acetate. Animal reproduction studies have not been conducted with calcium acetate capsules, and there are no adequate and well controlled studies of calcium acetate capsules 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 capsules treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.

🧒 Pediatric Use 13 words ▾

8.4PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 83 words ▾

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 the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 24 words ▾

10. OVERDOSAGE Administration of calcium acetate capsules in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1) ]

🧬 Clinical Pharmacology 117 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 (calcium acetate capsules) 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.

🧬 Mechanism of Action 36 words ▾

12.1MECHANISM OF ACTION Calcium acetate (calcium acetate capsules) 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 79 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING Each calcium acetate capsule USP, for oral administration, contains 667 mg of Calcium Acetate, USP (anhydrous Ca (CH 3 COO) 2 ; MW=158.17 grams) equivalent to 169 mg (8.45 mEq) of calcium. The capsules are size 00EL with light green opaque cap and white opaque body with black imprint on cap "NC" above "667".

NDC 69367-411-02 Bottles of 200 STORAGE: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP "Controlled Room Temperature"].

📦 Storage and Handling 15 words ▾

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

📋 Description 165 words ▾

11. DESCRIPTION Calcium acetate capsules, USP act 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 capsule for oral administration contains 667 mg of calcium acetate, USP (anhydrous; Ca(CH 3 COO) 2 ; MW=158.17 grams) equivalent to 169 mg (8.45 mEq) of calcium and the inactive ingredients magnesium stearate and polyethylene glycol. The capsules are size 00EL with light green opaque cap and white opaque body with black imprint on cap "NC" above "667".

The gelatin capsules contain D&C Yellow #10, FD&C Blue #1, FD&C Red #40, titanium dioxide and gelatin. The imprinting ink contains the following: black iron oxide, D&C Yellow # 10 Aluminum Lake, FD&C Blue #1/ Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/ Indigo Carmine Aluminum Lake, FD&C Red # 40/ Allura Red AC Aluminum Lake, propylene glycol and shellac glaze. USP dissolution test is pending.

Chemical Structure

💬 Information for Patients 86 words ▾

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 and efficancy to take the drug one hour before or three hours after calcium acetate capsules.

🍼 Nursing Mothers 40 words ▾

8.3NURSING MOTHERS Calcium acetate capsules contain calcium acetate and is excreted in human milk. Human milk feeding by a mother receiving calcium acetate capsules is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored.

🧬 Pharmacodynamics 43 words ▾

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.

🔬 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 Ninety-one patients completed at least 6 weeks of the study. Week 8 Week 12 p-value ANOVA of difference in values at pre-study and study completion. Phosphorous (mg/dL) Values expressed as mean ± SE.

7.4± 0.17 5.9 ± 0.16 5.6 ± 0.17 5.2 ± 0.17 ≤0.01 Calcium (mg/dL) 8.9 ± 0.09 9.5 ± 0.10 9.7 ± 0.10 9.7 ± 0.10 ≤0.01 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 doubleblind, 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 Post-Treatment Parameter Pre-Study Calcium Acetate Placebo p-value ANOVA of calcium acetate vs. placebo after 2 weeks of treatment. Phosphorous (mg/dL) Values expressed as mean ± SE.

7.3± 0.18 5.9 ± 0.24 7.8 ± 0.22 <0.01 Calcium (mg/dL) 8.9 ± 0.11 9.5 ± 0.13 8.8 ± 0.12 <0.01 Overall, 2 weeks of treatment with calcium acetate statistically significantally (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 23 words ▾

13. NONCLINICAL TOXICOLOGY

13.1CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY No carcinogenicity, mutagenicity, or fertility studies have been conducted with calcium acetate.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 20 words ▾

13.1CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY No carcinogenicity, mutagenicity, or fertility studies have been conducted with calcium acetate.

📄 Package Label / Principal Display Panel 32 words ▾

PRINCIPAL DISPLAY PANEL - 667 mg Capsule Bottle Label NDC: 69367-411-02 Rx Only Calcium Acetate Capsules, USP 667 mg* 200 Capsules Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 667 mg Capsule Bottle 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.
📅 Q3 2025 – Q4 2025 · 2 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
582
Units reimbursed last 4 qtrs
115.9K
Gross reimbursed last 4 qtrs
$31.3K
Avg / prescription
$53.75
Avg / unit
$0.2699
Latest quarter Q4 2025
514Rx
Medicaid pays / ea
$0.2699
gross reimbursed
vs
NADAC / ea
$0.1697
acquisition cost
=
Spread
+$0.1002
+59% 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 ⓘ
58% FFS 42% MCO
Fee-for-service · 335 Rx Managed care · 247 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,844 units · 23.6 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 1,682 units · 29.3 per 100k residents MN Wisconsin: no data reported WI Michigan: 10,156 units · 101 per 100k residents MI New York: 11,960 units · 61.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 6,536 units · 55.5 per 100k residents OH Pennsylvania: 5,995 units · 46.3 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 58,944 units · 151 per 100k residents CA Utah: no data reported UT Colorado: 2,541 units · 43.2 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 3,100 units · 68.5 per 100k residents KY West Virginia: 3,900 units · 220 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 2,220 units · 72.4 per 100k residents AR Tennessee: no data reported TN North Carolina: 1,964 units · 18.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 5,064 units · 353 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
18.1353
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 353 /100k
2 West Virginia 220 /100k
3 California 151 /100k
4 Michigan 101 /100k
5 Arkansas 72.4 /100k
6 Kentucky 68.5 /100k
7 New York 61.1 /100k
8 Ohio 55.5 /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.
← 69367-0410-01 · Westminster 69367-0412-60 · Westminster →
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.