DILTIAZEM HYDROCHLORIDE

Product NDC
51754-3000
11-digit product format
517543000
Labeler code
51754
Product ID
51754-3000_8380def7-7f6c-48f1-84ba-935077479130
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Exela Pharma Sciences,LLC
Application
NDA215252
Marketing category
NDA
Marketing start
2021-11-30
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51754-3000-32025-12-03C16284748780-12cef2736-8a60-d83d-e063-dadaa90ab31f51ddc49b-f2b5-4e79-93f5-e236fb546a66
51754-3000-32025-01-30C16284748780-12cef2736-8a60-d83d-e063-dadaa90ab31f51ddc49b-f2b5-4e79-93f5-e236fb546a66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-3000DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [EXELA PHARMA SCIENCES,LLC]1Legacy NDC20211130_51ddc49b-f2b5-4e79-93f5-e236fb546a66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51754-3000-35175430000310 BAG in 1 CARTON (51754-3000-3) > 125 mL in 1 BAG10 bag2021-11-300000-00-00NoNoCurrent