Midazolam

Product NDC
76045-211
11-digit product format
760450211
Labeler code
76045
Product ID
76045-211_ec9c9aee-b95f-4645-bf17-df7f1e3967d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA203460
Marketing category
ANDA
Marketing start
2021-04-16
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
2 mg/2mL
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
76045-211-207604502112024 BLISTER PACK in 1 CARTON (76045-211-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-211-00) / 2 mL in 1 SYRINGE, GLASS24 blister pack2021-04-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Midazolam Injection, USP CIVFresenius Kabi USA, LLC2024-01-01HUMAN PRESCRIPTION DRUG LABEL16