diltiazem hydrochloride

Product NDC
71335-9708
11-digit product format
713359708
Labeler code
71335
Product ID
71335-9708_3753529d-bd12-9887-e063-6294a90a75f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206534
Marketing category
ANDA
Marketing start
2017-09-28
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
180 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
71335-9708-17133597080130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9708-1) 2025-06-11NoNoHistorical
71335-9708-27133597080290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9708-2) 2023-05-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diltiazem Hydrochloride Extended-Release Capsules, USP Rx onlyBryant Ranch Prepack2025-06-11HUMAN PRESCRIPTION DRUG LABEL102