Midazolam

Product NDC
52584-081
11-digit product format
525840081
Labeler code
52584
Product ID
52584-081_4dd02e66-ded4-43d8-b592-31c11f05f7da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA075154
Marketing category
ANDA
Marketing start
2019-07-09
Marketing end
2023-06-30
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
52584-081-13525840081131 VIAL in 1 BAG (52584-081-13) > 10 mL in 1 VIAL1 vial2019-07-090000-00-00NoNoCurrent