etomidate

Product NDC
65841-818
11-digit product format
658410818
Labeler code
65841
Product ID
65841-818_069985f2-a43c-4b79-a5d8-fb7583e9ef91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etomidate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Lifesciences Limited
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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETOMIDATEACTIVE INGREDIENTZ22628B598ETOMIDATE INJECTION, SOLUTION [CADILA HEALTHCARE LIMITED]1
ETOMIDATEACTIVE MOIETYZ22628B598ETOMIDATE INJECTION, SOLUTION [CADILA HEALTHCARE LIMITED]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ETOMIDATE INJECTION, SOLUTION [CADILA HEALTHCARE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-818ETOMIDATE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED]5Legacy NDC20221108_428d51f4-fb7a-4efe-a87e-698d46ef8a24.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-818-076584108180710 VIAL in 1 TRAY (65841-818-07) > 10 mL in 1 VIAL10 vial2015-04-030000-00-00NoNoCurrent
65841-818-086584108180810 VIAL in 1 TRAY (65841-818-08) > 20 mL in 1 VIAL10 vial2015-04-030000-00-00NoNoCurrent