FDA.reportPublic FDA data

Etomidate

Product NDC
72572-161
11-digit product format
725720161
Labeler code
72572
Product ID
72572-161_380f0c88-03f8-4cfa-8823-4766c2f7700c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etomidate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA202354
Marketing category
ANDA
Marketing start
2022-03-01
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
72572-161-01Etomidate20 mL in 1 VIAL, SINGLE-DOSEINJECTION204
72572-161-10Etomidate10 in 1 CARTONINJECTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-161-01ML - Milliliter72572-161db4d13df-1e6f-4164-bce4-eab8b915636212022-08-04
72572-161-10ML - Milliliter72572-16122f5ed8e-4fe1-4ade-b354-3e2963a7d9c612022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-161ETOMIDATE INJECTION [CIVICA, INC.]4Current NDC, Legacy NDC, 2 package rows20250418_98002094-f065-4b5f-963f-2c34b5241316.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654006etomidate 20 MG in 10 ML InjectionPSN98002094-f065-4b5f-963f-2c34b52413164
1654008etomidate 40 MG in 20 ML InjectionPSN98002094-f065-4b5f-963f-2c34b52413164
165400610 ML etomidate 2 MG/ML InjectionSCD98002094-f065-4b5f-963f-2c34b52413164
165400820 ML etomidate 2 MG/ML InjectionSCD98002094-f065-4b5f-963f-2c34b52413164
1654006etomidate 20 MG per 10 ML InjectionSY98002094-f065-4b5f-963f-2c34b52413164
1654008etomidate 40 MG per 20 ML InjectionSY98002094-f065-4b5f-963f-2c34b52413164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-161-017257201610120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
72572-161-107257201611010 VIAL, SINGLE-DOSE in 1 CARTON (72572-161-10) / 20 mL in 1 VIAL, SINGLE-DOSE (72572-161-01) 2022-03-010000-00-00NoNoCurrent