Midazolam

Product NDC
52584-059
11-digit product format
525840059
Labeler code
52584
Product ID
52584-059_6b7741e7-bbb2-4d29-bd74-f2f4d93f058a
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
2018-03-05
Marketing end
2024-10-31
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
1 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
52584-059-01525840059011 VIAL in 1 BAG (52584-059-01) > 5 mL in 1 VIAL1 vial2018-03-050000-00-00NoNoCurrent