Midazolam

Product NDC
52584-055
11-digit product format
525840055
Labeler code
52584
Product ID
52584-055_3611ac48-c23b-4457-9aea-4de37824d197
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA075243
Marketing category
ANDA
Marketing start
2017-11-28
Marketing end
2021-09-30
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-055-01525840055011 VIAL in 1 BAG (52584-055-01) > 10 mL in 1 VIAL1 vial2017-11-282021-09-30NoNoCurrent