FDA.reportPublic FDA data

Cardizem CD

Product NDC
0187-0798
11-digit product format
001870798
Labeler code
0187
Product ID
0187-0798_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
300 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020062-001CARDIZEM CDDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB3RLD1992-08-10
N020062-002CARDIZEM CDDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB3RLD1991-12-27
N020062-003CARDIZEM CDDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB3RLD1991-12-27
N020062-004CARDIZEM CDDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB3RLD1991-12-27
N020062-005CARDIZEM CDDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB3RLD, RS1999-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
N020062-001AB3
N020062-002AB3
N020062-003AB3
N020062-004AB3
N020062-005AB3

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020062-001CARDIZEM CD120MGCAPSULE, EXTENDED RELEASE / ORALAB3RLD1992-08-10a50c72e98297…
2026-08-01 22:54:322026-06N020062-002CARDIZEM CD180MGCAPSULE, EXTENDED RELEASE / ORALAB3RLD1991-12-27a50c72e98297…
2026-08-01 22:54:322026-06N020062-003CARDIZEM CD240MGCAPSULE, EXTENDED RELEASE / ORALAB3RLD1991-12-27a50c72e98297…
2026-08-01 22:54:322026-06N020062-004CARDIZEM CD300MGCAPSULE, EXTENDED RELEASE / ORALAB3RLD1991-12-27a50c72e98297…
2026-08-01 22:54:322026-06N020062-005CARDIZEM CD360MGCAPSULE, EXTENDED RELEASE / ORALAB3RLD, RS1999-08-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020062-001AB31a50c72e98297…
2026-08-01 22:54:322026-06N020062-002AB31a50c72e98297…
2026-08-01 22:54:322026-06N020062-003AB31a50c72e98297…
2026-08-01 22:54:322026-06N020062-004AB31a50c72e98297…
2026-08-01 22:54:322026-06N020062-005AB31a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cardizem CDDILTIAZEM HYDROCHLORIDEBausch Health US LLC1042fa13-e6af-46b9-8008-6c941f0978b12025-12-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 020062
application number: NDA020062
ndc (product): 0187-0798

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OLH94387TEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830795Internal RxNorm lookup
830798Internal RxNorm lookup
830801Internal RxNorm lookup
830803Internal RxNorm lookup
830837Internal RxNorm lookup
830839Internal RxNorm lookup
830845Internal RxNorm lookup
830847Internal RxNorm lookup
830861Internal RxNorm lookup
830863Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1042fa13-e6af-46b9-8008-6c941f0978b1Available on FDA.report

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
0187-0798-30Cardizem CD30 in 1 BOTTLE, PLASTICCAPSULE, COATED, EXTENDED RELEAS3025
0187-0798-42Cardizem CD90 in 1 BOTTLE, PLASTICCAPSULE, COATED, EXTENDED RELEAS9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0798-30EA - Each0187-0798fd32a105-e74a-4503-9525-0f0cc083622a12012-07-24
0187-0798-42EA - Each0187-0798fbec3948-0cd5-4ce6-bc5a-7d83afbadbf712012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0798CARDIZEM CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [BAUSCH HEALTH US LLC]24Current NDC, Legacy NDC, 2 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0187-0798-300018707983030 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0798-30) 2001-04-110000-00-00NoNoCurrent
0187-0798-420018707984290 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0798-42) 2001-04-110000-00-00NoNoCurrent