Calcium Acetate
Calcium Acetate CapsulesThese 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 for ORAL use.Initial U.S. Approval: 1990
Approved
Approval ID
e3308b35-d0d0-4134-9c21-30d21d583bde
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2016
Manufacturers
FDA
LUPIN LIMITED
DUNS: 675923163
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 Code57297-134
Application NumberANDA202127
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcium Acetate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2016
FDA Product Classification
INGREDIENTS (12)
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CALCIUM ACETATEActive
Quantity: 667 mg in 1 1
Code: Y882YXF34X
Classification: ACTIB
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT