MIDAZOLAM HYDROCHLORIDE

Product NDC
51754-2131
11-digit product format
517542131
Labeler code
51754
Product ID
51754-2131_5aa322a4-0b10-4f41-ba56-508fc2b25229
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIDAZOLAM HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Exela Pharma Sciences, LLC
Application
NDA215868
Marketing category
NDA
Marketing start
2022-12-01
Marketing end
0000-00-00
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51754-2131-42025-12-03C16284748780-12cef2736-8ec3-d83d-e063-dadaa90ab31f7b42059c-16ad-4826-829b-83b42a39435b
51754-2131-42025-01-30C16284748780-12cef2736-8ec3-d83d-e063-dadaa90ab31f7b42059c-16ad-4826-829b-83b42a39435b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-2131-4ML - Milliliter51754-2131fa85417b-ff5f-4270-98e2-471843009b1312023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-2131MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]2Legacy NDC20221217_7b42059c-16ad-4826-829b-83b42a39435b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51754-2131-45175421310425 VIAL in 1 CARTON (51754-2131-4) > 100 mL in 1 VIAL25 vial2022-12-010000-00-00NoNoCurrent