Midazolam

Product NDC
0409-0001
11-digit product format
004090001
Labeler code
0409
Product ID
0409-0001_74093865-864a-49e8-99b9-c985fe72afb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIDAZOLAM HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA075857
Marketing category
ANDA
Marketing start
2025-01-27
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
W7TTW573JJMIDAZOLAM HYDROCHLORIDE59467-96-8MIDAZOLAM HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0409-0001-250040900012525 VIAL, SINGLE-DOSE in 1 CARTON (0409-0001-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-0001-01) 2025-01-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Midazolam CIV Injection, USPHospira, Inc.2026-04-27HUMAN PRESCRIPTION DRUG LABEL34