Diltiazem Hydrochloride

Product NDC
67046-1481
11-digit product format
670461481
Labeler code
67046
Product ID
67046-1481_2ced5dc5-47e0-1b71-e063-6394a90a0e3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA074910
Marketing category
ANDA
Marketing start
2025-01-30
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
67046-1481-36704614810330 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1481-3) 2025-01-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diltiazem Hydrochloride - Coupler LLCCoupler LLC2025-01-30HUMAN PRESCRIPTION DRUG LABEL1