FDA.reportPublic FDA data

Etomidate

Product NDC
0143-9507
11-digit product format
001439507
Labeler code
0143
Product ID
0143-9507_98560882-bfdf-404e-ab8b-3ee2a6875830
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etomidate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA202354
Marketing category
ANDA
Marketing start
2016-02-25
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
0143-9507-01Etomidate20 mL in 1 VIAL, SINGLE-DOSEINJECTION206
0143-9507-10Etomidate10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9507-01ML - Milliliter0143-950706481ec8-797b-4272-b36f-940306a7485e12016-10-06
0143-9507-10ML - Milliliter0143-95074211648e-97ce-494f-b63f-ff70ef08da5d12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9507ETOMIDATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20231207_75bf0494-7cb9-4e8a-8edd-af62f035d236.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654006etomidate 20 MG in 10 ML InjectionPSN75bf0494-7cb9-4e8a-8edd-af62f035d2366
1654008etomidate 40 MG in 20 ML InjectionPSN75bf0494-7cb9-4e8a-8edd-af62f035d2366
165400610 ML etomidate 2 MG/ML InjectionSCD75bf0494-7cb9-4e8a-8edd-af62f035d2366
165400820 ML etomidate 2 MG/ML InjectionSCD75bf0494-7cb9-4e8a-8edd-af62f035d2366
1654006etomidate 20 MG per 10 ML InjectionSY75bf0494-7cb9-4e8a-8edd-af62f035d2366
1654008etomidate 40 MG per 20 ML InjectionSY75bf0494-7cb9-4e8a-8edd-af62f035d2366

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9507-010014395070120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
0143-9507-100014395071010 VIAL, SINGLE-DOSE in 1 CARTON (0143-9507-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0143-9507-01) 2016-02-250000-00-00NoNoCurrent