midazolam

Product NDC
25021-655
11-digit product format
250210655
Labeler code
25021
Product ID
25021-655_943346c0-d98e-4ac2-a1a2-75427decf2fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midazolam hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA090696
Marketing category
ANDA
Marketing start
2012-03-19
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-655-022502106550210 VIAL in 1 CARTON (25021-655-02) / 2 mL in 1 VIAL10 vial2012-03-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Midazolam Injection, USP CIV (For Intravenous or Intramuscular Use Only)Sagent Pharmaceuticals2023-11-03HUMAN PRESCRIPTION DRUG LABEL14