Midazolam

Product NDC
0641-6281
11-digit product format
006416281
Labeler code
0641
Product ID
0641-6281_9ed8a0bb-bfd0-4f63-aa40-9813dd4a8f4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA075243
Marketing category
ANDA
Marketing start
2000-06-20
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
R60L0SM5BCMIDAZOLAM59467-70-8Midazolam

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0641-6281-250064162812525 VIAL in 1 CARTON (0641-6281-25) / 2 mL in 1 VIAL (0641-6281-01) 25 vial2000-06-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Midazolam Injection, USP - NOVAPLUS®Hikma Pharmaceuticals USA Inc.2024-12-17HUMAN PRESCRIPTION DRUG LABEL8