TIADYLT ER

Product NDC
71335-9719
11-digit product format
713359719
Labeler code
71335
Product ID
71335-9719_377c5eca-9482-002a-e063-6294a90a9454
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206641
Marketing category
ANDA
Marketing start
2017-11-08
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
OLH94387TEDILTIAZEM HYDROCHLORIDE33286-22-5DILTIAZEM HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9719-17133597190130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9719-1) 2025-06-12NoNoHistorical
71335-9719-27133597190228 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9719-2) 2025-06-12NoNoHistorical
71335-9719-37133597190390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9719-3) 2025-06-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TIADYLT ER (diltiazem hydrochloride extended-release) Capsules, USP Rx onlyBryant Ranch Prepack2025-06-13HUMAN PRESCRIPTION DRUG LABEL103