FDA.reportPublic FDA data

Cardizem LA

Product NDC
0187-2048
11-digit product format
001872048
Labeler code
0187
Product ID
0187-2048_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
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830874, 830876, 830877, 830878, 830879, 830880, 830882, 830883, 830897, 830898, 830900, 830902

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
0187-2048-30Cardizem LA30 in 1 BOTTLETABLET, EXTENDED RELEASE3019
0187-2048-90Cardizem LA90 in 1 BOTTLETABLET, EXTENDED RELEASE9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-2048-30EA - Each0187-204874659954-4e09-48df-be07-a300de3bc68112014-12-01
0187-2048-90EA - Each0187-204878b3bd40-b64f-43dd-90d4-0c0048caa7a212015-01-05

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
0187-2048CARDIZEM 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
0187-2048-300018720483030 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2048-30) 2010-12-250000-00-00NoNoCurrent
0187-2048-900018720489090 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2048-90) 2010-12-250000-00-00NoNoCurrent