Cardizem LA (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 180 mg Bottle Label

NDC 0187-2046-90

Rx only

CARDIZEM® LA
(Diltiazem Hydrochloride)Extended-Release Tablets

180 mg

90 Tablets

Valeant

Cardizem-180mg-90tab.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 240 mg Bottle Label

NDC 0187-2047-90

Rx only

CARDIZEM® LA
(Diltiazem Hydrochloride)Extended-Release Tablets

240 mg

90 Tablets

VALEANT

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PRINCIPAL DISPLAY PANEL — 300 mg Bottle Label

NDC 187-2048-90

Rx only

CARDIZEM® LA
(Diltiazem Hydrochloride)Extended-Release Tablets

300 mg

90 Tablets

Valeant

C:\Users\Denise.Eady\Pictures\cardizem 300mg90-0187-2048-90.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 360 mg Bottle Label

NDC 0187-2049-90

Rx only

CARDIZEM® LA
(Diltiazem Hydrochloride)Extended-Release Tablets

360 mg

90 Tablets

VALEANT

C:\Users\Denise.Eady\Pictures\cardizemla-0187-2049-90.png
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 420 mg Bottle Label

NDC 0187-2050-90

Rx only

CARDIZEM® LA
(Diltiazem Hydrochloride)Extended-Release Tablets

420 mg

90 Tablets

VALEANT

//medlibrary.org/lib/images-rx/cardizem-la-2/label-420mg-300x177.jpg
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CARDIZEM LA diltiazem hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-2045
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride (Diltiazem) Diltiazem Hydrochloride 120 mg
Inactive Ingredients
Ingredient Name Strength
carnauba wax
silicon dioxide
croscarmellose sodium
ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)
HYPROMELLOSE, UNSPECIFIED
magnesium stearate
MICROCRYSTALLINE CELLULOSE
microcrystalline wax
polydextrose
POLYETHYLENE GLYCOL, UNSPECIFIED
polysorbate 80
POVIDONE, UNSPECIFIED
sucrose stearate
talc
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (Capsule-shaped) Size 13mm
Flavor Imprint Code B;120;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-2045-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0187-2045-90 90 TABLET, EXTENDED RELEASE 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 Item Code (Source) NDC:0187-2046
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride (Diltiazem) Diltiazem Hydrochloride 180 mg
Inactive Ingredients
Ingredient Name Strength
carnauba wax
silicon dioxide
croscarmellose sodium
ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)
HYPROMELLOSE, UNSPECIFIED
magnesium stearate
MICROCRYSTALLINE CELLULOSE
microcrystalline wax
polydextrose
POLYETHYLENE GLYCOL, UNSPECIFIED
polysorbate 80
POVIDONE, UNSPECIFIED
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
# Item Code Package Description Multilevel Packaging
1 NDC:0187-2046-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0187-2046-90 90 TABLET, EXTENDED RELEASE 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 Item Code (Source) NDC:0187-2047
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 and methyl methacrylate copolymer (2:1; 750000 mw)
HYPROMELLOSE, UNSPECIFIED
magnesium stearate
MICROCRYSTALLINE CELLULOSE
microcrystalline wax
polydextrose
POLYETHYLENE GLYCOL, UNSPECIFIED
polysorbate 80
POVIDONE, UNSPECIFIED
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
# Item Code Package Description Multilevel Packaging
1 NDC:0187-2047-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0187-2047-90 90 TABLET, EXTENDED RELEASE 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 Item Code (Source) NDC:0187-2048
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 and methyl methacrylate copolymer (2:1; 750000 mw)
HYPROMELLOSE, UNSPECIFIED
magnesium stearate
MICROCRYSTALLINE CELLULOSE
microcrystalline wax
polydextrose
POLYETHYLENE GLYCOL, UNSPECIFIED
polysorbate 80
POVIDONE, UNSPECIFIED
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
# Item Code Package Description Multilevel Packaging
1 NDC:0187-2048-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0187-2048-90 90 TABLET, EXTENDED RELEASE 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 Item Code (Source) NDC:0187-2049
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 and methyl methacrylate copolymer (2:1; 750000 mw)
HYPROMELLOSE, UNSPECIFIED
magnesium stearate
MICROCRYSTALLINE CELLULOSE
microcrystalline wax
polydextrose
POLYETHYLENE GLYCOL, UNSPECIFIED
polysorbate 80
POVIDONE, UNSPECIFIED
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
# Item Code Package Description Multilevel Packaging
1 NDC:0187-2049-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0187-2049-90 90 TABLET, EXTENDED RELEASE 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 Item Code (Source) NDC:0187-2050
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 and methyl methacrylate copolymer (2:1; 750000 mw)
HYPROMELLOSE, UNSPECIFIED
magnesium stearate
MICROCRYSTALLINE CELLULOSE
microcrystalline wax
polydextrose
POLYETHYLENE GLYCOL, UNSPECIFIED
polysorbate 80
POVIDONE, UNSPECIFIED
sucrose stearate
talc
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (Capsule-shaped) Size 19mm
Flavor Imprint Code B;420;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-2050-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0187-2050-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021392 12/25/2010
Labeler — Valeant Pharmaceuticals North America LLC (042230623)
Registrant — Valeant Pharmaceuticals North America LLC (042230623)
Establishment
Name Address ID/FEI Operations
Valeant Pharmaceuticals International, Inc. 253292734 MANUFACTURE (0187-2045), MANUFACTURE (0187-2046), MANUFACTURE (0187-2047), MANUFACTURE (0187-2048), MANUFACTURE (0187-2049), MANUFACTURE (0187-2050)

Revised: 11/2016 Valeant Pharmaceuticals North America LLC

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