NDC Code(s) : 0187-0795-30, 0187-0795-42, 0187-0795-49, 0187-0796-30, 0187-0796-42, 0187-0796-49, 0187-0796-50, 0187-0797-30, 0187-0797-42, 0187-0797-49, 0187-0798-30, 0187-0798-42, 0187-0799-42
Packager : Bausch Health US LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cardizem CDdiltiazem hydrochloride CAPSULE, COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0795
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride(UNII: OLH94387TE)
(Diltiazem - UNII:EE92BBP03H) 		Diltiazem Hydrochloride120 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)300 mg in 1 1
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
MAGNESIUM STEARATE(UNII: 70097M6I30)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
SUCROSE STEARATE(UNII: 274KW0O50M)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color BLUE (light turquoise blue,light turquoise blue) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code cardizem;CD;120;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0187-0795-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/11/2001
2NDC:0187-0795-4290 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/11/2001
3NDC:0187-0795-4910 in 1 BOX, UNIT-DOSE 04/11/2001
310 in 1 BLISTER PACK Type 0: Not a Combination Product04/11/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020062 04/11/2001
Cardizem CDdiltiazem hydrochloride CAPSULE, COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0796
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride(UNII: OLH94387TE)
(Diltiazem - UNII:EE92BBP03H) 		Diltiazem Hydrochloride180 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)300 mg in 1 1
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
MAGNESIUM STEARATE(UNII: 70097M6I30)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
SUCROSE STEARATE(UNII: 274KW0O50M)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color BLUE (Light turquoise blue, blue) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code cardizem;CD;180;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0187-0796-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/11/2001
2NDC:0187-0796-4290 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/11/2001
3NDC:0187-0796-4910 in 1 BOX, UNIT-DOSE 04/11/2001
310 in 1 BLISTER PACK Type 0: Not a Combination Product04/11/2001
4NDC:0187-0796-505000 in 1 DRUM Type 0: Not a Combination Product04/11/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020062 04/11/2001
Cardizem CDdiltiazem hydrochloride CAPSULE, COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0797
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride(UNII: OLH94387TE)
(Diltiazem - UNII:EE92BBP03H) 		Diltiazem Hydrochloride240 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)300 mg in 1 1
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
MAGNESIUM STEARATE(UNII: 70097M6I30)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
SUCROSE STEARATE(UNII: 274KW0O50M)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color BLUE (blue, blue) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code cardizem;CD;240;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0187-0797-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/11/2001
2NDC:0187-0797-4290 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/11/2001
3NDC:0187-0797-4910 in 1 BOX, UNIT-DOSE 04/11/2001
310 in 1 BLISTER PACK Type 0: Not a Combination Product04/11/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020062 04/11/2001
Cardizem CDdiltiazem hydrochloride CAPSULE, COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0798
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride(UNII: OLH94387TE)
(Diltiazem - UNII:EE92BBP03H) 		Diltiazem Hydrochloride300 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)300 mg in 1 1
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
MAGNESIUM STEARATE(UNII: 70097M6I30)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
SUCROSE STEARATE(UNII: 274KW0O50M)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color GRAY (Light gray , BLUE (Light blue)) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code cardizem;CD;300;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0187-0798-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/11/2001
2NDC:0187-0798-4290 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/11/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020062 04/11/2001
Cardizem CDdiltiazem hydrochloride CAPSULE, COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0799
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride(UNII: OLH94387TE)
(Diltiazem - UNII:EE92BBP03H) 		Diltiazem Hydrochloride360 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)300 mg in 1 1
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
MAGNESIUM STEARATE(UNII: 70097M6I30)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
SUCROSE STEARATE(UNII: 274KW0O50M)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color BLUE (Light blue, WHITE (white)) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code cardizem;CD;360;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0187-0799-4290 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/11/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020062 04/11/2001

LABELER - Bausch Health US LLC(831922468)

Establishment
Name Address ID/FEI Business Operations
Bausch Health Companies Inc. 253292734 MANUFACTURE(0187-0799, 0187-0795, 0187-0796, 0187-0797, 0187-0798)

PRINCIPAL DISPLAY PANEL

NDC 0187-0795-42

Rx only

CARDIZEM® CD

(diltiazem hydrochloride)

Extended-Release Capsules
ONCE-A-DAY
DOSAGE

120 mg

90 Capsules

BAUSCH HEALTH

120 LABEL

PRINCIPAL DISPLAY PANEL

NDC 0187-0796-42

Rx only

CARDIZEM® CD

(diltiazem hydrochloride)

Extended-Release Capsules
ONCE-A-DAY
DOSAGE

180 mg

90 Capsules

BAUSCH HEALTH

180 LABEL

PRINCIPAL DISPLAY PANEL

NDC 0187-0797-42

Rx only

CARDIZEM® CD

(diltiazem hydrochloride)

Extended-Release Capsules
ONCE-A-DAY
DOSAGE

240 mg

90 Capsules

BAUSCH HEALTH

240MG LABEL

PRINCIPAL DISPLAY PANEL

NDC 0187-0798-42

Rx only

CARDIZEM® CD

(diltiazem hydrochloride)

Extended-Release Capsules
ONCE-A-DAY
DOSAGE

300 mg

90 Capsules

BAUSCH HEALTH

300MG LABEL

PRINCIPAL DISPLAY PANEL

NDC 0187-0799-42

Rx only

CARDIZEM® CD

(diltiazem hydrochloride)

Extended-Release Capsules
ONCE-A-DAY DOSAGE

360 mg

90 Capsules

BAUSCH HEALTH

360MG LABEL