em Hydrochloride 180 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 15mm
Flavor Imprint Code B;180;mg
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0074-3061-30 30 TABLET In 1 BOTTLE None
2 0074-3061-90 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) 0074-3062
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride (Diltiazem) Diltiazem Hydrochloride 240 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 17mm
Flavor Imprint Code B;240;mg
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0074-3062-30 30 TABLET In 1 BOTTLE None
2 0074-3062-90 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) 0074-3063
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride (Diltiazem) Diltiazem Hydrochloride 300 mg
Inactive Ingredients
Ingredient Name Strength
carnauba wax
silicon dioxide
croscarmellose sodium
ethyl acrylate - methyl methacrylate copolymer
hypromelloses
magnesium stearate
cellulose, microcryst |
