Diltiazem Hydrochloride

Product NDC
25021-319
11-digit product format
250210319
Labeler code
25021
Product ID
25021-319_13a2c20f-bf6f-4dad-938e-6f4ff99a689a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA074617
Marketing category
ANDA
Marketing start
2024-06-01
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
5 mg/mL
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
25021-319-052502103190510 VIAL in 1 CARTON (25021-319-05) / 5 mL in 1 VIAL10 vial2024-06-01NoNoHistorical
25021-319-102502103191010 VIAL in 1 CARTON (25021-319-10) / 10 mL in 1 VIAL10 vial2024-06-01NoNoHistorical
25021-319-252502103192510 VIAL in 1 CARTON (25021-319-25) / 25 mL in 1 VIAL10 vial2024-06-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diltiazem Hydrochloride InjectionMedical Purchasing Solutions, LLC | Medical Purchasing Solutions, LLC.2025-10-23HUMAN PRESCRIPTION DRUG LABEL1
Diltiazem Hydrochloride InjectionProPharma Distribution2025-09-18HUMAN PRESCRIPTION DRUG LABEL1
Diltiazem Hydrochloride InjectionSagent Pharmaceuticals2024-04-08HUMAN PRESCRIPTION DRUG LABEL1