FDA.reportPublic FDA data

Calcium Acetate

Product NDC
0054-0088
11-digit product format
000540088
Labeler code
0054
Product ID
0054-0088_bd03f7bd-1e38-4419-a991-c7f39cee364d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA077728
Marketing category
ANDA
Marketing start
2008-02-26
Substance
CALCIUM ACETATE
Active strength
667 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calcium Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM ACETATE667 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY882YXF34X
Rxcui359296

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0088-13Calcium Acetate30 in 1 BOTTLECAPSULE308
0054-0088-26Calcium Acetate200 in 1 BOTTLECAPSULE2008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0088-13EA - Each0054-00881816028c-e1b3-4966-8280-f56046a8541c12013-08-02
0054-0088-26EA - Each0054-0088b92d7f5a-eb53-429e-a35a-8aa3ef760dcc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM ACETATEACTIVE INGREDIENTY882YXF34XCALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
ALCOHOLINACTIVE INGREDIENT3K9958V90MCALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
GELATININACTIVE INGREDIENT2G86QN327LCALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
SHELLACINACTIVE INGREDIENT46N107B71OCALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCIUM ACETATE CAPSULE [ATLANTIC BIOLOGICALS CORPS]7
CALCIUM ACETATEACTIVE INGREDIENTY882YXF34XCALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MCALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
GELATININACTIVE INGREDIENT2G86QN327LCALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
SHELLACINACTIVE INGREDIENT46N107B71OCALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCIUM ACETATE CAPSULE [ROXANE LABORATORIES, INC]5
CALCIUM ACETATEACTIVE INGREDIENTY882YXF34XCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CALCIUMACTIVE MOIETYSY7Q814VUPCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
GELATININACTIVE INGREDIENT2G86QN327LCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SHELLACINACTIVE INGREDIENT46N107B71OCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CALCIUM ACETATEACTIVE INGREDIENTY882YXF34XCALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
GELATININACTIVE INGREDIENT2G86QN327LCALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
SHELLACINACTIVE INGREDIENT46N107B71OCALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCIUM ACETATE CAPSULE [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0088CALCIUM ACETATE CAPSULE [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20250419_85fd41f8-2823-44ca-a15e-f1f2e5d0ff94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSN1090762c-eec1-4ab0-9ddc-43caa764cd0e8
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSN85fd41f8-2823-44ca-a15e-f1f2e5d0ff948
359296calcium acetate 667 MG Oral CapsuleSCD1090762c-eec1-4ab0-9ddc-43caa764cd0e8
359296calcium acetate 667 MG Oral CapsuleSCD85fd41f8-2823-44ca-a15e-f1f2e5d0ff948
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSY1090762c-eec1-4ab0-9ddc-43caa764cd0e8
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSY85fd41f8-2823-44ca-a15e-f1f2e5d0ff948
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSNbd529f97-35a1-4701-ba67-7f5999f97a657
359296calcium acetate 667 MG Oral CapsuleSCDbd529f97-35a1-4701-ba67-7f5999f97a657
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSYbd529f97-35a1-4701-ba67-7f5999f97a657
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSN9a731cdf-6488-44ca-b97f-512a0e9deab15
359296calcium acetate 667 MG Oral CapsuleSCD9a731cdf-6488-44ca-b97f-512a0e9deab15
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSY9a731cdf-6488-44ca-b97f-512a0e9deab15
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSN5edaed4c-4294-418b-a3bd-28b17f67381f2
359296calcium acetate 667 MG Oral CapsuleSCD5edaed4c-4294-418b-a3bd-28b17f67381f2
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSY5edaed4c-4294-418b-a3bd-28b17f67381f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0088-130005400881330 CAPSULE in 1 BOTTLE (0054-0088-13) 30 capsule2008-02-280000-00-00NoNoCurrent
0054-0088-2600054008826200 CAPSULE in 1 BOTTLE (0054-0088-26) 200 capsule2008-02-280000-00-00NoNoCurrent