Etomidate

Product NDC
68083-235
11-digit product format
680830235
Labeler code
68083
Product ID
68083-235_3e4fa967-6ab9-4de0-af94-f9c479504b20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etomidate Injection
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA209058
Marketing category
ANDA
Marketing start
2017-05-20
Substance
ETOMIDATE
Active strength
2 mg/mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Etomidate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETOMIDATE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ22628B598
Rxcui1654006, 1654008

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fe0c5d6c-1467-3506-5566-aee700997367Product name520210610

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-235-01Etomidate20 mL in 1 VIALSOLUTION205
68083-235-10Etomidate10 in 1 CARTONSOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-235ETOMIDATE (ETOMIDATE INJECTION) SOLUTION [GLAND PHARMA LIMITED]5Current NDC, Legacy NDC, 2 package rows20171018_94cde4e7-3b46-419f-8dda-87675da8d89d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654006etomidate 20 MG in 10 ML InjectionPSN94cde4e7-3b46-419f-8dda-87675da8d89d5
1654008etomidate 40 MG in 20 ML InjectionPSN94cde4e7-3b46-419f-8dda-87675da8d89d5
165400610 ML etomidate 2 MG/ML InjectionSCD94cde4e7-3b46-419f-8dda-87675da8d89d5
165400820 ML etomidate 2 MG/ML InjectionSCD94cde4e7-3b46-419f-8dda-87675da8d89d5
1654006etomidate 20 MG per 10 ML InjectionSY94cde4e7-3b46-419f-8dda-87675da8d89d5
1654008etomidate 40 MG per 20 ML InjectionSY94cde4e7-3b46-419f-8dda-87675da8d89d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-235-016808302350120 mL in 1 VIAL20 mlHistorical
68083-235-106808302351010 VIAL in 1 CARTON (68083-235-10) / 20 mL in 1 VIAL (68083-235-01) 10 vial2017-05-200000-00-00NoNoCurrent