FDA.reportPublic FDA data

TIADYLT ER

Product NDC
68382-747
11-digit product format
683820747
Labeler code
68382
Product ID
68382-747_16e01600-83e9-4996-8b2b-c175d92a205a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA206641
Marketing category
ANDA
Marketing start
2017-11-08
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
240 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
TIADYLT ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830795, 830801, 830837, 830845, 830861, 831359, 1988308, 1988311, 1988316, 1988319, 1988324, 1988330

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
68382-747-01TIADYLT ER100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1005
68382-747-05TIADYLT ER500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5005
68382-747-06TIADYLT ER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
68382-747-10TIADYLT ER1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10005
68382-747-16TIADYLT ER90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-747-06EA - Each68382-7473a1c094a-5e5f-4911-97b2-0499a07f292112020-04-20
68382-747-16EA - Each68382-747080565cd-ff86-4490-908c-026efd23efda12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-747TIADYLT ER (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5Current NDC, Legacy NDC, 5 package rows20250503_1278cd76-b8e9-42d9-ad19-6858e72cf9f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
831359dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
1988308TIADYLT ER 120 MG 24HR Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
1988311TIADYLT ER 180 MG 24HR Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
1988316TIADYLT ER 240 MG 24HR Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
1988319TIADYLT ER 300 MG 24HR Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
1988324TIADYLT ER 360 MG 24HR Extended Release Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
1988330TIADYLT ER 420 MG 24HR Oral CapsulePSN1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198830824 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule [Tiadylt]SBD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198831124 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule [Tiadylt]SBD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198831624 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule [Tiadylt]SBD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198831924 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule [Tiadylt]SBD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198832424 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule [Tiadylt]SBD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198833024 HR diltiazem hydrochloride 420 MG Extended Release Oral Capsule [Tiadylt]SBD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
83135924 HR diltiazem hydrochloride 420 MG Extended Release Oral CapsuleSCD1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198830824 HR Tiadylt 120 MG Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198831124 HR Tiadylt 180 MG Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198831624 HR Tiadylt 240 MG Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198831924 HR Tiadylt 300 MG Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198832424 HR Tiadylt 360 MG Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25
198833024 HR Tiadylt 420 MG Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25
831359diltiazem hydrochloride 420 MG 24 HR Extended Release Oral CapsuleSY1278cd76-b8e9-42d9-ad19-6858e72cf9f25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-747-0168382074701100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-747-01) 2017-11-080000-00-00NoNoCurrent
68382-747-0568382074705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-747-05) 2017-11-080000-00-00NoNoCurrent
68382-747-066838207470630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-747-06) 2017-11-080000-00-00NoNoCurrent
68382-747-10683820747101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-747-10) 2017-11-080000-00-00NoNoCurrent
68382-747-166838207471690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-747-16) 2017-11-080000-00-00NoNoCurrent