Calcium Acetate
Calcium Acetate Capsules 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, for oral use Initial U.S. Approval: 1990
Approved
Approval ID
781c3f1f-b622-418b-8c0e-3407e9b90656
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2023
Manufacturers
FDA
Chartwell RX, LLC.
DUNS: 079394054
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 Code62135-191
Application NumberANDA091312
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcium Acetate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (19)
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
SILICA, TRIMETHYLSILYL CAPPEDInactive
Code: VU10KU4B9S
Classification: IACT
CALCIUM ACETATEActive
Quantity: 667 mg in 1 1
Code: Y882YXF34X
Classification: ACTIB