NDC Code(s) : 55154-4961-6, 55154-4961-4, 55154-4961-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Calcium AcetateCalcium Acetate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4961(NDC:0054-0088)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM ACETATE(UNII: Y882YXF34X)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM ACETATE667 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color WHITE (Blue Opaque) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code 54215
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4961-4200 in 1 CARTON 26/02/2008
1NDC:55154-4961-61 in 1 POUCH Type 0: Not a Combination Product
2NDC:55154-4961-010 in 1 BAG 26/02/2008
2NDC:55154-4961-61 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077728 02/26/2008

PRINCIPAL DISPLAY PANEL

Calcium Acetate Capsules

667 mg

200 Capsules

carton label

PRINCIPAL DISPLAY PANEL

Calcium Acetate Capsule

667 mg

pouch

PRINCIPAL DISPLAY PANEL

Calcium Acetate Capsules

667 mg

10 Capsules

bag label