Diltiazem Hydrochloride

Product NDC
42799-130
11-digit product format
427990130
Labeler code
42799
Product ID
42799-130_5b90e43a-b550-4a28-b9f8-5f1b4663201a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA211596
Marketing category
ANDA
Marketing start
2018-10-29
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
60 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
42799-130-01EA - Each42799-1303c18c953-1e63-4ec6-97e3-d70bbdcd0b1d12020-04-20
42799-130-02EA - Each42799-13026f6c7b8-162d-41a5-bb39-9f6190a7246012020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-130DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [EDENBRIDGE PHARMACEUTICALS LLC.]6Legacy NDC20220115_14a67570-6820-46ee-920c-b6d3663609d9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42799-130-0142799013001100 TABLET, FILM COATED in 1 BOTTLE (42799-130-01) 2018-10-290000-00-00NoNoCurrent
42799-130-0242799013002500 TABLET, FILM COATED in 1 BOTTLE (42799-130-02) 2018-10-290000-00-00NoNoCurrent