FDA.reportPublic FDA data

Cardizem LA

Product NDC
0187-2045
11-digit product format
001872045
Labeler code
0187
Product ID
0187-2045_1771fff3-92c3-48ee-b786-5d6d7c6e6628
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bausch Health US LLC
Application
NDA021392
Marketing category
NDA
Marketing start
2010-12-25
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021392-001CARDIZEM LADILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06
N021392-002CARDIZEM LADILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06
N021392-003CARDIZEM LADILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06
N021392-004CARDIZEM LADILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06
N021392-005CARDIZEM LADILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06
N021392-006CARDIZEM LADILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N021392-001AB
N021392-002AB
N021392-003AB
N021392-004AB
N021392-005AB
N021392-006AB

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 22:54:322026-06N021392-001CARDIZEM LA120MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06a50c72e98297…
2026-08-01 22:54:322026-06N021392-002CARDIZEM LA180MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06a50c72e98297…
2026-08-01 22:54:322026-06N021392-003CARDIZEM LA240MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06a50c72e98297…
2026-08-01 22:54:322026-06N021392-004CARDIZEM LA300MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06a50c72e98297…
2026-08-01 22:54:322026-06N021392-005CARDIZEM LA360MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06a50c72e98297…
2026-08-01 22:54:322026-06N021392-006CARDIZEM LA420MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-02-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021392-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021392-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N021392-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N021392-004AB1a50c72e98297…
2026-08-01 22:54:322026-06N021392-005AB1a50c72e98297…
2026-08-01 22:54:322026-06N021392-006AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cardizem LADILTIAZEM HYDROCHLORIDEBausch Health US LLC3e180dc7-c871-4efc-8755-cae882976c8d2025-11-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 021392
application number: NDA021392
ndc (product): 0187-2045
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETSOceanside Pharmaceuticals73b3607a-99d0-44d8-92ef-0074684c9d7d2025-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021392
application number: NDA021392

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE120 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 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830874Internal RxNorm lookup
830876Internal RxNorm lookup
830877Internal RxNorm lookup
830878Internal RxNorm lookup
830879Internal RxNorm lookup
830880Internal RxNorm lookup
830882Internal RxNorm lookup
830883Internal RxNorm lookup
830897Internal RxNorm lookup
830898Internal RxNorm lookup
830900Internal RxNorm lookup
830902Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e180dc7-c871-4efc-8755-cae882976c8dAvailable 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
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-2045-30Cardizem LA30 in 1 BOTTLETABLET, EXTENDED RELEASE3019
0187-2045-90Cardizem LA90 in 1 BOTTLETABLET, EXTENDED RELEASE9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-2045-30EA - Each0187-2045b4ba0f2e-e08f-4f8e-9df3-23396f426ca112014-06-03
0187-2045-90EA - Each0187-2045b149d9ee-2e3e-4e63-97f5-a3d749134e5012014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diltiazem HydrochlorideACTIVE INGREDIENTOLH94387TECARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
DiltiazemACTIVE MOIETYEE92BBP03HCARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
carnauba waxINACTIVE INGREDIENTR12CBM0EIZCARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)INACTIVE INGREDIENTP2OM2Q86BICARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
magnesium stearateINACTIVE INGREDIENT70097M6I30CARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KYCARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
polydextroseINACTIVE INGREDIENTVH2XOU12IECARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
sucrose stearateINACTIVE INGREDIENT274KW0O50MCARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
talcINACTIVE INGREDIENT7SEV7J4R1UCARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-2045CARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BAUSCH HEALTH US LLC]16Current NDC, Legacy NDC, 2 package rows20250503_3e180dc7-c871-4efc-8755-cae882976c8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830876CARDIZEM LA 120 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
830878CARDIZEM LA 180 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
830880CARDIZEM LA 240 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
830883CARDIZEM LA 300 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
830898CARDIZEM LA 360 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
830902CARDIZEM LA 420 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
830874dilTIAZem hydrochloride 120 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
830877dilTIAZem hydrochloride 180 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
830879dilTIAZem hydrochloride 240 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
830882dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
830897dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
830900dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral TabletPSN3e180dc7-c871-4efc-8755-cae882976c8d19
83087624 HR diltiazem hydrochloride 120 MG Extended Release Oral Tablet [Cardizem]SBD3e180dc7-c871-4efc-8755-cae882976c8d19
83087824 HR diltiazem hydrochloride 180 MG Extended Release Oral Tablet [Cardizem]SBD3e180dc7-c871-4efc-8755-cae882976c8d19
83088024 HR diltiazem hydrochloride 240 MG Extended Release Oral Tablet [Cardizem]SBD3e180dc7-c871-4efc-8755-cae882976c8d19
83088324 HR diltiazem hydrochloride 300 MG Extended Release Oral Tablet [Cardizem]SBD3e180dc7-c871-4efc-8755-cae882976c8d19
83089824 HR diltiazem hydrochloride 360 MG Extended Release Oral Tablet [Cardizem]SBD3e180dc7-c871-4efc-8755-cae882976c8d19
83090224 HR diltiazem hydrochloride 420 MG Extended Release Oral Tablet [Cardizem]SBD3e180dc7-c871-4efc-8755-cae882976c8d19
83087424 HR diltiazem hydrochloride 120 MG Extended Release Oral TabletSCD3e180dc7-c871-4efc-8755-cae882976c8d19
83087724 HR diltiazem hydrochloride 180 MG Extended Release Oral TabletSCD3e180dc7-c871-4efc-8755-cae882976c8d19
83087924 HR diltiazem hydrochloride 240 MG Extended Release Oral TabletSCD3e180dc7-c871-4efc-8755-cae882976c8d19
83088224 HR diltiazem hydrochloride 300 MG Extended Release Oral TabletSCD3e180dc7-c871-4efc-8755-cae882976c8d19
83089724 HR diltiazem hydrochloride 360 MG Extended Release Oral TabletSCD3e180dc7-c871-4efc-8755-cae882976c8d19
83090024 HR diltiazem hydrochloride 420 MG Extended Release Oral TabletSCD3e180dc7-c871-4efc-8755-cae882976c8d19
83087624 HR Cardizem 120 MG Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
83087824 HR Cardizem 180 MG Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
83088024 HR Cardizem 240 MG Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
83088324 HR Cardizem 300 MG Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
83089824 HR Cardizem 360 MG Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
83090224 HR Cardizem 420 MG Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830876Cardizem LA 120 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830878Cardizem LA 180 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830880Cardizem LA 240 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830883Cardizem LA 300 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830898Cardizem LA 360 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830902Cardizem LA 420 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830874diltiazem hydrochloride 120 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830877diltiazem hydrochloride 180 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830879diltiazem hydrochloride 240 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830882diltiazem hydrochloride 300 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830897diltiazem hydrochloride 360 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19
830900diltiazem hydrochloride 420 MG 24 HR Extended Release Oral TabletSY3e180dc7-c871-4efc-8755-cae882976c8d19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0187-2045-300018720453030 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-30) 2010-12-250000-00-00NoNoCurrent
0187-2045-900018720459090 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-90) 2010-12-250000-00-00NoNoCurrent