Calcium Acetate

Product NDC
65162-590
11-digit product format
651620590
Labeler code
65162
Product ID
65162-590_726db9f7-007a-466c-ba47-41149ee217be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA201658
Marketing category
ANDA
Marketing start
2014-10-08
Marketing end
0000-00-00
Substance
CALCIUM ACETATE
Active strength
667 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-590-20EA - Each65162-5901185a975-24c4-4371-ae5a-05e9dc6577ff12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM ACETATEACTIVE INGREDIENTY882YXF34XCALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
ALCOHOLINACTIVE INGREDIENT3K9958V90MCALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
GELATININACTIVE INGREDIENT2G86QN327LCALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
SHELLACINACTIVE INGREDIENT46N107B71OCALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-590CALCIUM ACETATE CAPSULE [AMNEAL PHARMACEUTICALS LLC]15Legacy NDC20241025_5bbed4df-5883-49fc-adae-1af4073bb860.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-590-1065162059010100 CAPSULE in 1 BOTTLE (65162-590-10) 100 capsule2014-10-080000-00-00NoNoCurrent
65162-590-2065162059020200 CAPSULE in 1 BOTTLE (65162-590-20) 200 capsule2014-10-080000-00-00NoNoCurrent
65162-590-5065162059050500 CAPSULE in 1 BOTTLE (65162-590-50) 500 capsule2014-10-080000-00-00NoNoCurrent