FDA.reportPublic FDA data

Etomidate

Product NDC
67457-903
11-digit product format
674570903
Labeler code
67457
Product ID
67457-903_25fc0aef-d4b3-4b33-897c-81cc7cdae470
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etomidate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA201044
Marketing category
ANDA
Marketing start
2019-03-01
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
67457-903-00Etomidate20 mL in 1 VIALINJECTION, SOLUTION203
67457-903-20Etomidate10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-903-00ML - Milliliter67457-903b907dc3f-c7c2-47d4-9aaf-3c31afb6d97512019-04-11
67457-903-20ML - Milliliter67457-90359200ba5-376e-4e60-a153-82040846a52c12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-903ETOMIDATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]3Current NDC, Legacy NDC, 2 package rows20240531_461e34d1-b862-4a02-9727-548c907aac48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654006etomidate 20 MG in 10 ML InjectionPSN461e34d1-b862-4a02-9727-548c907aac483
1654008etomidate 40 MG in 20 ML InjectionPSN461e34d1-b862-4a02-9727-548c907aac483
165400610 ML etomidate 2 MG/ML InjectionSCD461e34d1-b862-4a02-9727-548c907aac483
165400820 ML etomidate 2 MG/ML InjectionSCD461e34d1-b862-4a02-9727-548c907aac483
1654006etomidate 20 MG per 10 ML InjectionSY461e34d1-b862-4a02-9727-548c907aac483
1654008etomidate 40 MG per 20 ML InjectionSY461e34d1-b862-4a02-9727-548c907aac483

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-903-006745709030020 mL in 1 VIAL20 mlHistorical
67457-903-206745709032010 VIAL in 1 CARTON (67457-903-20) / 20 mL in 1 VIAL (67457-903-00) 10 vial2019-03-010000-00-00NoNoCurrent