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Calcium Acetate

Calcium Acetate Capsules

Approved
Approval ID

5edaed4c-4294-418b-a3bd-28b17f67381f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 12, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

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 Code53808-0216
Application NumberANDA077728
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcium Acetate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2010
FDA Product Classification

INGREDIENTS (14)

FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CALCIUM ACETATEActive
Quantity: 667 mg in 1 1
Code: Y882YXF34X
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT

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Calcium Acetate - FDA Drug Approval Details