FDA.reportPublic FDA data

Etomidate

Product NDC
0143-9311
11-digit product format
001439311
Labeler code
0143
Product ID
0143-9311_c15bd8c1-34e3-40f2-b31a-634136fe197c
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
0143-9311-01Etomidate20 mL in 1 VIAL, SINGLE-DOSEINJECTION206
0143-9311-10Etomidate10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9311-01ML - Milliliter0143-9311db67b793-3e93-4ab0-addb-13266a292fda12018-10-11
0143-9311-10ML - Milliliter0143-9311bec70db3-62d9-4e7a-b6eb-ab36fcd97f2b12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9311ETOMIDATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20231121_4312e3c3-34de-4cb3-8abd-c24d24a4bea1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654006etomidate 20 MG in 10 ML InjectionPSN4312e3c3-34de-4cb3-8abd-c24d24a4bea16
1654008etomidate 40 MG in 20 ML InjectionPSN4312e3c3-34de-4cb3-8abd-c24d24a4bea16
165400610 ML etomidate 2 MG/ML InjectionSCD4312e3c3-34de-4cb3-8abd-c24d24a4bea16
165400820 ML etomidate 2 MG/ML InjectionSCD4312e3c3-34de-4cb3-8abd-c24d24a4bea16
1654006etomidate 20 MG per 10 ML InjectionSY4312e3c3-34de-4cb3-8abd-c24d24a4bea16
1654008etomidate 40 MG per 20 ML InjectionSY4312e3c3-34de-4cb3-8abd-c24d24a4bea16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9311-010014393110120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
0143-9311-100014393111010 VIAL, SINGLE-DOSE in 1 CARTON (0143-9311-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0143-9311-01) 2016-02-250000-00-00NoNoCurrent