alline
microcrystalline wax
polydextrose
polyethylene glycol
polysorbate 80
povidone
sucrose stearate
talc
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (Capsule-shaped) Size 18mm
Flavor Imprint Code B;300;mg
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0074-3063-30 30 TABLET In 1 BOTTLE None
2 0074-3063-90 90 TABLET In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021392 12/25/2010
CARDIZEM LA
diltiazem hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0074-3064
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride (Diltiazem) Diltiazem Hydrochloride 360 mg
Inactive Ingredients
Ingredient Name Strength
carnauba wax
silicon dioxide
croscarmellose sodium
ethyl acrylate - methyl methacrylate copolymer
hypromelloses
magnesium stearate
cellulose, microcrystalline
microcrystalline wax
polydextrose
polyethylene glycol
polysorbate 80
povidone
sucrose stearate
talc
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (Capsule-shaped) Size 19mm
Flavor Imprint Code B;360;mg
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0074-3064-30 30 TABLET In 1 BOTTLE None
2 0074-3064-90 90 TABLET In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021392 12/25/2010
CARDIZEM LA
diltiazem hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0074-3069
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride (Diltiazem) Diltiazem Hydrochloride 420 mg
Inactive Ingredients
Ingredient Name Strength
carnauba wax
silicon dioxide
croscarmellose sodium
ethyl acrylate - methyl methacrylate copolymer
hypromelloses
magnesium stearate
cellulose, microcrystalline
microcrystalline wax
polydextrose
polyethylene glycol
polysorbate 80
povidone
sucrose stearate
talc
titanium dioxide
Product Characteristics
Color WHIT |
