etomidate

Product NDC
68382-545
11-digit product format
683820545
Labeler code
68382
Product ID
68382-545_22814fa3-e57a-4f2c-bab5-e9f44b0132b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etomidate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA202360
Marketing category
ANDA
Marketing start
2015-04-03
Marketing end
0000-00-00
Substance
ETOMIDATE
Active strength
2 mg/mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-545ETOMIDATE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]4Legacy NDC20221118_8b71a0a4-d3e7-49a9-b40e-976c94f2eb6b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-545-076838205450710 VIAL in 1 TRAY (68382-545-07) > 10 mL in 1 VIAL10 vial2015-04-030000-00-00NoNoCurrent
68382-545-086838205450810 VIAL in 1 TRAY (68382-545-08) > 20 mL in 1 VIAL10 vial2015-04-030000-00-00NoNoCurrent