FDA.reportPublic FDA data

Calcium Acetate

Product NDC
82804-968
11-digit product format
828040968
Labeler code
82804
Product ID
82804-968_80c15366-9420-41c2-8817-b9c39ddfcec1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203179
Marketing category
ANDA
Marketing start
2025-06-13
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
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
82804-968-00Calcium Acetate100 in 1 BOTTLECAPSULE1001
82804-968-20Calcium Acetate20 in 1 BOTTLECAPSULE201
82804-968-30Calcium Acetate30 in 1 BOTTLECAPSULE301
82804-968-55Calcium Acetate500 in 1 BOTTLECAPSULE5001
82804-968-60Calcium Acetate60 in 1 BOTTLECAPSULE601
82804-968-64Calcium Acetate240 in 1 BOTTLECAPSULE2401
82804-968-72Calcium Acetate120 in 1 BOTTLECAPSULE1201
82804-968-78Calcium Acetate180 in 1 BOTTLECAPSULE1801
82804-968-90Calcium Acetate90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-968-00EA - Each82804-968a066c647-be8d-486c-b50d-46fadfd6a2b312025-08-11
82804-968-20EA - Each82804-968bae54742-5e6a-4fa7-95c4-5efd93bce2c212025-08-11
82804-968-30EA - Each82804-968d5a64ec1-5d74-4d28-b14b-44a254d2859e12025-08-11
82804-968-55EA - Each82804-96853b383cc-0654-44fe-8a6b-19afc39d4e6f12025-08-11
82804-968-60EA - Each82804-968aa756e48-a62e-4a4b-bf8d-ab9729d39c7912025-08-11
82804-968-64EA - Each82804-96889e8bde8-adf4-4fdb-b238-86bbd9dc967c12025-08-11
82804-968-72EA - Each82804-968930073b5-b8a6-4489-b9a8-72262c0d687012025-08-11
82804-968-78EA - Each82804-968d022a3c9-3583-4038-afa4-26d8c6bb152712025-08-11
82804-968-90EA - Each82804-968dacdf539-9cfa-4a0e-ae6f-81581971560312025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSN80c15366-9420-41c2-8817-b9c39ddfcec11
359296calcium acetate 667 MG Oral CapsuleSCD80c15366-9420-41c2-8817-b9c39ddfcec11
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSY80c15366-9420-41c2-8817-b9c39ddfcec11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-968-0082804096800100 CAPSULE in 1 BOTTLE (82804-968-00) 100 capsule2025-06-25NoNoHistorical
82804-968-208280409682020 CAPSULE in 1 BOTTLE (82804-968-20) 20 capsule2025-06-25NoNoHistorical
82804-968-308280409683030 CAPSULE in 1 BOTTLE (82804-968-30) 30 capsule2025-06-25NoNoHistorical
82804-968-5582804096855500 CAPSULE in 1 BOTTLE (82804-968-55) 500 capsule2025-06-25NoNoHistorical
82804-968-608280409686060 CAPSULE in 1 BOTTLE (82804-968-60) 60 capsule2025-06-25NoNoHistorical
82804-968-6482804096864240 CAPSULE in 1 BOTTLE (82804-968-64) 240 capsule2025-06-25NoNoHistorical
82804-968-7282804096872120 CAPSULE in 1 BOTTLE (82804-968-72) 120 capsule2025-06-25NoNoHistorical
82804-968-7882804096878180 CAPSULE in 1 BOTTLE (82804-968-78) 180 capsule2025-06-25NoNoHistorical
82804-968-908280409689090 CAPSULE in 1 BOTTLE (82804-968-90) 90 capsule2025-06-25NoNoHistorical