Midazolam Hydrochloride

Product NDC
0904-7113
11-digit product format
009047113
Labeler code
0904
Product ID
0904-7113_2d62891b-06e1-4c21-bb7d-73b6aa19eb22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075873
Marketing category
ANDA
Marketing start
2002-04-30
Marketing end
0000-00-00
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7113-41ML - Milliliter0904-71136d9636b7-6c6d-4b03-a816-c7ebd76ef40412022-06-06
0904-7113-93ML - Milliliter0904-711364f4cf7c-cd33-4301-8c2d-e4a73cae1efa12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7113MIDAZOLAM HYDROCHLORIDE SYRUP [MAJOR PHARMACEUTICALS]4Legacy NDC20250206_2d62891b-06e1-4c21-bb7d-73b6aa19eb22.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-7113-930090471139330 CUP, UNIT-DOSE in 1 CASE (0904-7113-93) > 5 mL in 1 CUP, UNIT-DOSE (0904-7113-41) 2002-04-300000-00-00NoNoCurrent