Calcium Acetate

Product NDC
53808-0216
11-digit product format
538080216
Labeler code
53808
Product ID
53808-0216_67899f20-3cd2-4af1-ac3c-c46fced8a2f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077728
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
CALCIUM ACETATE
Active strength
667 mg/1
Pharmacologic classes
Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0216-12019-10-21C16284748780-1956f9ecf-d3e6-621f-e053-dbdaa90a74adCalcium Acetate Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0216-1Calcium Acetate30 in 1 BLISTER PACKCAPSULE302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0216CALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20100326_5edaed4c-4294-418b-a3bd-28b17f67381f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
53808-0216-15380802160130 in 1 BLISTER PACKHistorical