Midazolam Hydrochloride

Product NDC
52584-308
11-digit product format
525840308
Labeler code
52584
Product ID
52584-308_da7916ae-afc3-4d61-9681-a9dfb4bd77ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables & Vaccines, Inc
Application
ANDA075857
Marketing category
ANDA
Marketing start
2010-08-01
Marketing end
2023-09-01
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-308-01525840308011 VIAL, SINGLE-DOSE in 1 BAG (52584-308-01) > 1 mL in 1 VIAL, SINGLE-DOSE2010-08-010000-00-00NoNoCurrent
52584-308-02525840308021 VIAL, SINGLE-DOSE in 1 BAG (52584-308-02) > 2 mL in 1 VIAL, SINGLE-DOSE2010-08-010000-00-00NoNoCurrent