Diltiazem Hydrochloride

Product NDC
71335-0839
11-digit product format
713350839
Labeler code
71335
Product ID
71335-0839_3b27a1e2-8571-4d48-94cd-199a33329794
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA020401
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-08-20
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0839-2EA - Each71335-0839c5f91883-928b-49b7-8344-eb8ca2c85c7612025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0839DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]6Legacy NDC20231111_3b27a1e2-8571-4d48-94cd-199a33329794.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0839-17133508390130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0839-1) 2022-01-280000-00-00NoNoCurrent
71335-0839-27133508390290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0839-2) 2018-05-230000-00-00NoNoCurrent