Diltiazem Hydrochloride

Product NDC
67046-1492
11-digit product format
670461492
Labeler code
67046
Product ID
67046-1492_2cd90eaf-cc66-7b68-e063-6294a90a9737
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA216521
Marketing category
ANDA
Marketing start
2025-01-29
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
30 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1492-36704614920330 TABLET in 1 BLISTER PACK (67046-1492-3) 30 tablet2025-01-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diltiazem Hydrochloride Tablets, USP TabletsCoupler LLC2025-01-29HUMAN PRESCRIPTION DRUG LABEL1