Midazolam

Product NDC
47781-588
11-digit product format
477810588
Labeler code
47781
Product ID
47781-588_4aed3b8a-5bb3-bd09-39d9-20fd954265da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midazolam hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Alvogen Inc.
Application
ANDA090696
Marketing category
ANDA
Marketing start
2017-08-11
Marketing end
2022-04-01
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
2 mg/2mL
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-588-46ML - Milliliter47781-588509c17b4-9dcf-4ef5-a0e8-e580fa779ea112017-10-13
47781-588-68ML - Milliliter47781-58855641b36-d41d-46d1-ba20-2f5162f0361c12017-09-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-588-684778105886825 VIAL, SINGLE-DOSE in 1 CARTON (47781-588-68) > 2 mL in 1 VIAL, SINGLE-DOSE (47781-588-46) 2017-08-112022-04-01NoNoCurrent