Calcium Acetate
These highlights do not include all the information needed to use calcium acetate capsules safely and effectively. See full prescribing information for calcium acetate capsules. Calcium Acetate Capsules USP, 667 mg Initial U.S. Approval: 1990
Approved
Approval ID
a5725f95-621e-425b-946d-434b3fec24eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2021
Manufacturers
FDA
EXELAN PHARMACEUTICALS, INC.
DUNS: 967795266
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcium Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-377
Application NumberANDA203135
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcium Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2021
FDA Product Classification
INGREDIENTS (8)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CALCIUM ACETATEActive
Quantity: 667 mg in 1 1
Code: Y882YXF34X
Classification: ACTIB
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT