FDA.reportPublic FDA data

TIAZAC

Product NDC
0187-2612
11-digit product format
001872612
Labeler code
0187
Product ID
0187-2612_fe0721cb-5bee-49c5-909b-3c7ea0e2e6c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bausch Health US, LLC
Application
NDA020401
Marketing category
NDA
Marketing start
2014-08-20
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

Additional Listing Data#

Finished product
Yes
Brand name base
TIAZAC
Brand name suffix
EXTENDED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830795, 830801, 830837, 830845, 830861, 831193, 831244, 831296, 831323, 831347, 831359, 831360

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
0187-2612-30TIAZACEXTENDED RELEASE30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE3011
0187-2612-90TIAZACEXTENDED RELEASE90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-2612-30EA - Each0187-2612d8f04f0a-c0e7-4264-a889-b246fce3117712014-10-03
0187-2612-90EA - Each0187-261215962d9e-c324-4e17-bb58-795e4cdc7cc012014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diltiazem hydrochlorideACTIVE INGREDIENTOLH94387TETIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
DiltiazemACTIVE MOIETYEE92BBP03HTIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHTIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BITIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDTIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
FD&C Green No. 3INACTIVE INGREDIENT3P3ONR6O1STIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOATIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
gelatinINACTIVE INGREDIENT2G86QN327LTIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ETIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
sucrose stearateINACTIVE INGREDIENT274KW0O50MTIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
talcINACTIVE INGREDIENT7SEV7J4R1UTIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-2612TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BAUSCH HEALTH US, LLC]10Current NDC, Legacy NDC, 2 package rows20250427_c567fe7e-887e-4291-a0d1-2dd3f25cbf25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831359dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831193Tiazac 120 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831244Tiazac 180 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831296Tiazac 240 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831323Tiazac 300 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831347Tiazac 360 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831360Tiazac 420 MG 24HR Extended Release Oral CapsulePSNc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83119324 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule [Tiazac]SBDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83124424 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule [Tiazac]SBDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83129624 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule [Tiazac]SBDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83132324 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule [Tiazac]SBDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83134724 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule [Tiazac]SBDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83136024 HR diltiazem hydrochloride 420 MG Extended Release Oral Capsule [Tiazac]SBDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83135924 HR diltiazem hydrochloride 420 MG Extended Release Oral CapsuleSCDc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83119324 HR Tiazac 120 MG Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83124424 HR Tiazac 180 MG Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83129624 HR Tiazac 240 MG Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83132324 HR Tiazac 300 MG Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
83134724 HR Tiazac 360 MG Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831359diltiazem hydrochloride 420 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831193Tiazac 120 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831244Tiazac 180 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831296Tiazac 240 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831323Tiazac 300 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831347Tiazac 360 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511
831360Tiazac 420 MG 24 HR Extended Release Oral CapsuleSYc567fe7e-887e-4291-a0d1-2dd3f25cbf2511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0187-2612-300018726123030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2612-30) 2014-08-200000-00-00NoNoCurrent
0187-2612-900018726129090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2612-90) 2014-08-200000-00-00NoNoCurrent