FDA.reportPublic FDA data

TIADYLT ER

Product NDC
70771-1037
11-digit product format
707711037
Labeler code
70771
Product ID
70771-1037_302fc306-6fbe-4567-b5ce-dcc5a45ba894
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
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
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1037-0TIADYLT ER1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10005
70771-1037-1TIADYLT ER100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1005
70771-1037-3TIADYLT ER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
70771-1037-5TIADYLT ER500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5005
70771-1037-9TIADYLT ER90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1037TIADYLT ER (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 5 package rows20250503_d88e3546-3984-4dc9-893a-a29e95804550.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
831359dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
1988308TIADYLT ER 120 MG 24HR Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
1988311TIADYLT ER 180 MG 24HR Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
1988316TIADYLT ER 240 MG 24HR Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
1988319TIADYLT ER 300 MG 24HR Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
1988324TIADYLT ER 360 MG 24HR Extended Release Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
1988330TIADYLT ER 420 MG 24HR Oral CapsulePSNd88e3546-3984-4dc9-893a-a29e958045505
198830824 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule [Tiadylt]SBDd88e3546-3984-4dc9-893a-a29e958045505
198831124 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule [Tiadylt]SBDd88e3546-3984-4dc9-893a-a29e958045505
198831624 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule [Tiadylt]SBDd88e3546-3984-4dc9-893a-a29e958045505
198831924 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule [Tiadylt]SBDd88e3546-3984-4dc9-893a-a29e958045505
198832424 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule [Tiadylt]SBDd88e3546-3984-4dc9-893a-a29e958045505
198833024 HR diltiazem hydrochloride 420 MG Extended Release Oral Capsule [Tiadylt]SBDd88e3546-3984-4dc9-893a-a29e958045505
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDd88e3546-3984-4dc9-893a-a29e958045505
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDd88e3546-3984-4dc9-893a-a29e958045505
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDd88e3546-3984-4dc9-893a-a29e958045505
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDd88e3546-3984-4dc9-893a-a29e958045505
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCDd88e3546-3984-4dc9-893a-a29e958045505
83135924 HR diltiazem hydrochloride 420 MG Extended Release Oral CapsuleSCDd88e3546-3984-4dc9-893a-a29e958045505
198830824 HR Tiadylt 120 MG Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505
198831124 HR Tiadylt 180 MG Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505
198831624 HR Tiadylt 240 MG Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505
198831924 HR Tiadylt 300 MG Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505
198832424 HR Tiadylt 360 MG Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505
198833024 HR Tiadylt 420 MG Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505
831359diltiazem hydrochloride 420 MG 24 HR Extended Release Oral CapsuleSYd88e3546-3984-4dc9-893a-a29e958045505

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1037-0707711037001000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1037-0) 2017-11-080000-00-00NoNoCurrent
70771-1037-170771103701100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1037-1) 2017-11-080000-00-00NoNoCurrent
70771-1037-37077110370330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1037-3) 2017-11-080000-00-00NoNoCurrent
70771-1037-570771103705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1037-5) 2017-11-080000-00-00NoNoCurrent
70771-1037-97077110370990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1037-9) 2017-11-080000-00-00NoNoCurrent