Diltiazem Hydrochloride

Product NDC
42799-131
11-digit product format
427990131
Labeler code
42799
Product ID
42799-131_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
90 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
42799-131-01EA - Each42799-1315bc9d623-61e8-4991-9447-3291d947744f12020-04-20
42799-131-02EA - Each42799-1319834c9b3-74c4-47c8-9cf6-6cedcc9cb57412020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-131DILTIAZEM 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
42799-131-0142799013101100 TABLET, FILM COATED in 1 BOTTLE (42799-131-01) 2018-10-290000-00-00NoNoCurrent
42799-131-0242799013102500 TABLET, FILM COATED in 1 BOTTLE (42799-131-02) 2018-10-290000-00-00NoNoCurrent