Indications and uses
Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
Calcium Acetate
- Manufacturer
- American Health Packaging
- Effective date
- 2026-01-08
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-05-31 21:55:03
Label at a glance#
ProductCalcium Acetate
Active ingredientCALCIUM ACETATE
Label structure18 sections
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.
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. Unit dose packages of 100 (10 x 10) NDC 68084-479-01 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
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 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 capsule.
4 CONTRAINDICATIONS
Patients with hypercalcemia.
5 WARNINGS AND PRECAUTIONS
5.1 Hypercalcemia
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.
5.2 Concomitant Use with Medications
Hypercalcemia may aggravate digitalis toxicity.
6 ADVERSE REACTIONS
Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1)].
6.1 Clinical 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.
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.
6.2 Postmarketing 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.
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.
7.1 Ciprofloxacin
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%.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
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.
8.2 Labor and Delivery
The effects of calcium acetate on labor and delivery are unknown.
8.3 Nursing 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.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric 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.
10 OVERDOSAGE
Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].
11 DESCRIPTION
Calcium acetate acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C 4H 6CaO 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 3COO) 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.
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.
12.1 Mechanism 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.
12.2 Pharmacodynamics
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.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity, mutagenicity, or fertility studies have been conducted with calcium acetate.
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.
Parameter | Pre-Study | Week 4* | Week 8 | Week 12 | p-value† |
Phosphorus (mg/dL) ‡ | 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 |
* Ninety-one patients completed at least 6 weeks of the study.
† ANOVA of difference in values at pre-study and study completion.
‡ Values expressed as mean ± SE.
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.
Parameter | Pre-Study | Post-Treatment | p-value* | |
Calcium Acetate | Placebo | |||
Phosphorus (mg/dL) † | 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 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%.
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.
Unit dose packages of 100 (10 x 10) NDC 68084-479-01
Storage
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
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 non-prescription 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.
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
PACKAGING INFORMATION
American Health Packaging unit dose blisters (see
How Supplied section) contain drug product from Hikma Pharmaceuticals USA Inc. as follows:
(667 mg / 100 UD) NDC 68084-479-01 packaged from NDC 0054-0088
Distributed by:
American Health Packaging
Columbus, OH 43217
8247901/0121
Package/Label Display Panel – Carton – 667 mg
NDC 68084- 479-01
Calcium Acetate
Capsules, USP
667 mg
100 Capsules (10 x 10) Rx Only
Each Capsule Contains:
667 mg calcium acetate, USP equivalent to 169 mg calcium.
Directions: SWALLOW CAPSULES: DO NOT CHEW.
Take as directed by your physician.
Usual Dosage: See full prescribing information.
Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn
or broken.
The drug product contained in this package is from
NDC # 0054-0088, Hikma Pharmaceuticals USA Inc.
Distributed by: American Health Packaging, Columbus,
Ohio 43217
047901
0247901/0824
Package/Label Display Panel – Blister – 667 mg
Calcium
Acetate Capsule, USP
667 mg
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | DataBar Limited | (01)00368084479014 | GTIN-14: 00368084479014 GTIN-12: 368084479014 UPC-A: 368084479014 EAN-13: 0368084479014 GTIN storage (14 digits): 00368084479014 | 667 mg Calciuam Acetate Capsules Carton.jpg |
| Barcode | DataBar Limited | (01)00368084479113 | GTIN-14: 00368084479113 GTIN-12: 368084479113 UPC-A: 368084479113 EAN-13: 0368084479113 GTIN storage (14 digits): 00368084479113 | Blister.jpg |
| Data code | QR Code | dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=6808447901 | 667 mg Calciuam Acetate Capsules Carton.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bee4fa8d-8d82-423a-a0b5-40a89dd13a99 | Product name | 1 | 20250618 |
| e0d2eb29-08bd-4bba-90d1-c91c68a38767 | Product name | 4 | 20250516 |
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 334fe8d2-68fb-4331-a576-420e302ec069 | Product name | 7 | 20240320 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| e92765c1-be81-432a-b909-1b10777ec378 | Product name | 1 | 20190208 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 0441a8f5-3835-497c-aedd-bc78cba56b2a | Product name | 1 | 20150317 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68084-479-01 | Calcium Acetate | 100 in 1 CARTON | CAPSULE | 100 | 8 | |
| 68084-479-11 | Calcium Acetate | 1 in 1 BLISTER PACK | CAPSULE | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68084-479-01 | EA - Each | 68084-479 | 77771547-ebea-4b14-9e2b-9822a455f933 | 1 | 2013-09-04 |
| 68084-479-11 | EA - Each | 68084-479 | d0f3d525-a1b7-46af-b206-fd34f5584940 | 1 | 2013-09-04 |
| 0054-0088-13 | EA - Each | 0054-0088 | 1816028c-e1b3-4966-8280-f56046a8541c | 1 | 2013-08-02 |
| 0054-0088-26 | EA - Each | 0054-0088 | b92d7f5a-eb53-429e-a35a-8aa3ef760dcc | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CALCIUM ACETATE | ACTIVE INGREDIENT | Y882YXF34X | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Calcium Acetate
- POLYETHYLENE GLYCOL 8000
- MAGNESIUM STEARATE
- FD&C BLUE NO. 1
- FD&C RED NO. 3
- GELATIN, UNSPECIFIED
- TITANIUM DIOXIDE
- AMMONIA
- FERROSOFERRIC OXIDE
- ISOPROPYL ALCOHOL
- BUTYL ALCOHOL
- PROPYLENE GLYCOL
- SHELLAC
- CALCIUM CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68084-479 | 68084-479-11, 68084-479-01 |
| 0054-0088 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 3 | PN2ZH5LOQY | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| AMMONIA | 5138Q19F1X | IACT |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| BUTYL ALCOHOL | 8PJ61P6TS3 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SHELLAC | 46N107B71O | IACT |
| CALCIUM ACETATE | Y882YXF34X | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POLYETHYLENE GLYCOL 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | CAPSULE / ORAL | 180 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| POLYETHYLENE GLYCOL 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | CAPSULE / ORAL | 180 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE / ORAL | 34.48 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE / ORAL | 4 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE / ORAL | 34.48 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE / ORAL | 34.48 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| POLYETHYLENE GLYCOL 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | CAPSULE / ORAL | 180 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE / ORAL | 4 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| POLYETHYLENE GLYCOL 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | CAPSULE / ORAL | 180 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE / ORAL | 4 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE / ORAL | 4 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE / ORAL | 34.48 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077728-001 | CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077728-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A077728-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2008-02-26 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077728-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A077728-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077728-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077728-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077728-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077728-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077728-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077728-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077728-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077728-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077728-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077728-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077728-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077728-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077728-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077728-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077728-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077728-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077728-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077728-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077728-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077728-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077728-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077728-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077728-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077728-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077728-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077728-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077728-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077728-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077728-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077728-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077728-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077728-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077728-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077728-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077728-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077728-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077728-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077728-001 | AB | 1 | f41ea6bd6efb… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Calcium Acetate | CALCIUM ACETATE | American Health Packaging | 1090762c-eec1-4ab0-9ddc-43caa764cd0e | 2026-01-08 | Warnings, Adverse reactions | 68084-479-11 68084-479-01 68084-479 68084047911 68084047901 47e53e0e-be75-f24b-e063-6394a90a833f 1090762c-eec1-4ab0-9ddc-43caa764cd0e |
| Calcium Acetate | CALCIUM ACETATE | Hikma Pharmaceuticals USA Inc. | 85fd41f8-2823-44ca-a15e-f1f2e5d0ff94 | 2025-04-17 | Warnings, Adverse reactions | 0054-0088 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.