Diltiazem Hydrochloride

Product NDC
63629-2159
11-digit product format
636292159
Labeler code
63629
Product ID
63629-2159_7c51b805-577a-41a2-bf6f-b2058872b249
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074984
Marketing category
ANDA
Marketing start
2015-10-01
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
300 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
63629-2159-16362921590130 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (63629-2159-1) 2021-03-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diltiazem Hydrochloride Extended-Release Capsules, USP Rx OnlyBryant Ranch Prepack2024-01-10HUMAN PRESCRIPTION DRUG LABEL102