Cardizem

Product NDC
0187-0772
11-digit product format
001870772
Labeler code
0187
Product ID
0187-0772_340462fa-5523-448e-e063-6294a90a4eab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bausch Health US LLC
Application
NDA018602
Marketing category
NDA
Marketing start
2010-12-25
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
60 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui831054, 831055, 831102, 831103, 831137, 833217, 833219, 834393

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
0187-0772-47Cardizem100 in 1 BOTTLETABLET, COATED10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0772-47EA - Each0187-0772c399d9c0-28cf-4415-b683-e817f5fd156612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diltiazem HydrochlorideACTIVE INGREDIENTOLH94387TECARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
DiltiazemACTIVE MOIETYEE92BBP03HCARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
lactoseINACTIVE INGREDIENTJ2B2A4N98GCARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
magnesium stearateINACTIVE INGREDIENT70097M6I30CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0772CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [BAUSCH HEALTH US LLC]20Current NDC, Legacy NDC, 1 package rows20250502_f3e7ecef-f360-4987-a4f5-933214130ab2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831055Cardizem 120 MG Oral TabletPSNf3e7ecef-f360-4987-a4f5-933214130ab220
833219Cardizem 30 MG Oral TabletPSNf3e7ecef-f360-4987-a4f5-933214130ab220
834393Cardizem 60 MG Oral TabletPSNf3e7ecef-f360-4987-a4f5-933214130ab220
831137Cardizem 90 MG Oral TabletPSNf3e7ecef-f360-4987-a4f5-933214130ab220
831102dilTIAZem HCl 90 MG Oral TabletPSNf3e7ecef-f360-4987-a4f5-933214130ab220
831054dilTIAZem hydrochloride 120 MG Oral TabletPSNf3e7ecef-f360-4987-a4f5-933214130ab220
833217dilTIAZem hydrochloride 30 MG Oral TabletPSNf3e7ecef-f360-4987-a4f5-933214130ab220
831103dilTIAZem hydrochloride 60 MG Oral TabletPSNf3e7ecef-f360-4987-a4f5-933214130ab220
831055diltiazem hydrochloride 120 MG Oral Tablet [Cardizem]SBDf3e7ecef-f360-4987-a4f5-933214130ab220
833219diltiazem hydrochloride 30 MG Oral Tablet [Cardizem]SBDf3e7ecef-f360-4987-a4f5-933214130ab220
834393diltiazem hydrochloride 60 MG Oral Tablet [Cardizem]SBDf3e7ecef-f360-4987-a4f5-933214130ab220
831137diltiazem hydrochloride 90 MG Oral Tablet [Cardizem]SBDf3e7ecef-f360-4987-a4f5-933214130ab220
831054diltiazem hydrochloride 120 MG Oral TabletSCDf3e7ecef-f360-4987-a4f5-933214130ab220
833217diltiazem hydrochloride 30 MG Oral TabletSCDf3e7ecef-f360-4987-a4f5-933214130ab220
831103diltiazem hydrochloride 60 MG Oral TabletSCDf3e7ecef-f360-4987-a4f5-933214130ab220
831102diltiazem hydrochloride 90 MG Oral TabletSCDf3e7ecef-f360-4987-a4f5-933214130ab220
831055Cardizem 120 MG Oral TabletSYf3e7ecef-f360-4987-a4f5-933214130ab220
833219Cardizem 30 MG Oral TabletSYf3e7ecef-f360-4987-a4f5-933214130ab220
834393Cardizem 60 MG Oral TabletSYf3e7ecef-f360-4987-a4f5-933214130ab220
831137Cardizem 90 MG Oral TabletSYf3e7ecef-f360-4987-a4f5-933214130ab220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0187-0772-4700187077247100 TABLET, COATED in 1 BOTTLE (0187-0772-47) 2010-12-250000-00-00NoNoCurrent