FDA.reportPublic FDA data

Cardizem CD

Product NDC
0187-0797
11-digit product format
001870797
Labeler code
0187
Product ID
0187-0797_bb4d403f-465f-45df-b988-8e656d333f69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bausch Health US LLC
Application
NDA020062
Marketing category
NDA
Marketing start
2001-04-11
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
240 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cardizem CD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830795, 830798, 830801, 830803, 830837, 830839, 830845, 830847, 830861, 830863

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61ebbccf-eedf-453b-940e-dba67b7a5fefProduct name420260107
a8d6eaa3-afcc-47e5-be12-0c9251fc8740Product name120251124
f6700316-a6ba-5e59-3413-8ede05ae58b9Product name720250625
8615f7a1-1e8f-8281-8601-d7a637926d1fProduct name420250522
3a9daa2f-bcd1-13de-a1b4-6172caa7f308Product name220240419
f7129636-cba8-86c2-8bfb-9e2e2a9c7628Product name220240314
378290be-e30f-0e68-1201-165e93c337e8Product name320231212
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-0797-30Cardizem CD30 in 1 BOTTLE, PLASTICCAPSULE, COATED, EXTENDED RELEAS3025
0187-0797-42Cardizem CD90 in 1 BOTTLE, PLASTICCAPSULE, COATED, EXTENDED RELEAS9025
0187-0797-49Cardizem CD10 in 1 BLISTER PACKCAPSULE, COATED, EXTENDED RELEAS1025
0187-0797-49Cardizem CD10 in 1 BOX, UNIT-DOSECAPSULE, COATED, EXTENDED RELEAS1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0797-30EA - Each0187-07972538c727-a64c-4b1a-8b48-0b77c181622612012-07-24
0187-0797-42EA - Each0187-07976c36e3c5-1d5a-4e18-bfed-6d078e20c20112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diltiazem HydrochlorideACTIVE INGREDIENTOLH94387TECARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
DiltiazemACTIVE MOIETYEE92BBP03HCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
acetyltributyl citrateINACTIVE INGREDIENT0ZBX0N59RZCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
castor oilINACTIVE INGREDIENTD5340Y2I9GCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
diethyl phthalateINACTIVE INGREDIENTUF064M00AFCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
FD&C Blue no. 1INACTIVE INGREDIENTH3R47K3TBDCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357CARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
fumaric acidINACTIVE INGREDIENT88XHZ13131CARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
gelatinINACTIVE INGREDIENT2G86QN327LCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
povidoneINACTIVE INGREDIENTFZ989GH94ECARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
starch, cornINACTIVE INGREDIENTO8232NY3SJCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
sucroseINACTIVE INGREDIENTC151H8M554CARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
talcINACTIVE INGREDIENT7SEV7J4R1UCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
white waxINACTIVE INGREDIENT7G1J5DA97FCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Diltiazem HydrochlorideACTIVE INGREDIENTOLH94387TECARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
DiltiazemACTIVE MOIETYEE92BBP03HCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
acetyltributyl citrateINACTIVE INGREDIENT0ZBX0N59RZCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
castor oilINACTIVE INGREDIENTD5340Y2I9GCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C Blue no. 1INACTIVE INGREDIENTH3R47K3TBDCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357CARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
fumaric acidINACTIVE INGREDIENT88XHZ13131CARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
sucroseINACTIVE INGREDIENTC151H8M554CARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
white waxINACTIVE INGREDIENT7G1J5DA97FCARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0797CARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [BAUSCH HEALTH US LLC]24Current NDC, Legacy NDC, 4 package rows20250503_1042fa13-e6af-46b9-8008-6c941f0978b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830863Cardizem CD 120 MG 24HR Extended Release Oral CapsulePSN1042fa13-e6af-46b9-8008-6c941f0978b125
830847Cardizem CD 180 MG 24HR Extended Release Oral CapsulePSN1042fa13-e6af-46b9-8008-6c941f0978b125
830839Cardizem CD 240 MG 24HR Extended Release Oral CapsulePSN1042fa13-e6af-46b9-8008-6c941f0978b125
830803Cardizem CD 300 MG 24HR Extended Release Oral CapsulePSN1042fa13-e6af-46b9-8008-6c941f0978b125
830798Cardizem CD 360 MG 24HR Extended Release Oral CapsulePSN1042fa13-e6af-46b9-8008-6c941f0978b125
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN1042fa13-e6af-46b9-8008-6c941f0978b125
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN1042fa13-e6af-46b9-8008-6c941f0978b125
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN1042fa13-e6af-46b9-8008-6c941f0978b125
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN1042fa13-e6af-46b9-8008-6c941f0978b125
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSN1042fa13-e6af-46b9-8008-6c941f0978b125
83086324 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule [Cardizem]SBD1042fa13-e6af-46b9-8008-6c941f0978b125
83084724 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule [Cardizem]SBD1042fa13-e6af-46b9-8008-6c941f0978b125
83083924 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule [Cardizem]SBD1042fa13-e6af-46b9-8008-6c941f0978b125
83080324 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule [Cardizem]SBD1042fa13-e6af-46b9-8008-6c941f0978b125
83079824 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule [Cardizem]SBD1042fa13-e6af-46b9-8008-6c941f0978b125
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD1042fa13-e6af-46b9-8008-6c941f0978b125
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD1042fa13-e6af-46b9-8008-6c941f0978b125
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD1042fa13-e6af-46b9-8008-6c941f0978b125
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD1042fa13-e6af-46b9-8008-6c941f0978b125
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCD1042fa13-e6af-46b9-8008-6c941f0978b125
83086324 HR Cardizem 120 MG Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
83084724 HR Cardizem 180 MG Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
83083924 HR Cardizem 240 MG Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
83080324 HR Cardizem 300 MG Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
83079824 HR Cardizem 360 MG Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
830863Cardizem CD 120 MG 24 HR Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
830847Cardizem CD 180 MG 24 HR Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
830839Cardizem CD 240 MG 24 HR Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
830803Cardizem CD 300 MG 24 HR Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
830798Cardizem CD 360 MG 24 HR Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSY1042fa13-e6af-46b9-8008-6c941f0978b125
830839Cardizem CD 240 MG 24HR Extended Release Oral CapsulePSN1b67a7ed-32e9-432a-962e-4a424b9f46101
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN1b67a7ed-32e9-432a-962e-4a424b9f46101
83083924 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule [Cardizem]SBD1b67a7ed-32e9-432a-962e-4a424b9f46101
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD1b67a7ed-32e9-432a-962e-4a424b9f46101
83083924 HR Cardizem 240 MG Extended Release Oral CapsuleSY1b67a7ed-32e9-432a-962e-4a424b9f46101
830839Cardizem CD 240 MG 24 HR Extended Release Oral CapsuleSY1b67a7ed-32e9-432a-962e-4a424b9f46101
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY1b67a7ed-32e9-432a-962e-4a424b9f46101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0187-0797-300018707973030 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0797-30) 2001-04-110000-00-00NoNoCurrent
0187-0797-420018707974290 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0797-42) 2001-04-110000-00-00NoNoCurrent
0187-0797-490018707974910 in 1 BLISTER PACKHistorical