Etomidate

Product NDC
65145-128
11-digit product format
651450128
Labeler code
65145
Product ID
65145-128_6505a317-c1f5-46dc-852c-47c0db2fa134
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etomidate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA215028
Marketing category
ANDA
Marketing start
2026-02-05
Substance
ETOMIDATE
Active strength
2 mg/mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Etomidate
Listing expiration
2027-12-31

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
65145-128-01Etomidate20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION204
65145-128-10Etomidate10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-128ETOMIDATE INJECTION, SOLUTION [CAPLIN STERILES LIMITED]3Current NDC, Legacy NDC, 2 package rows20210316_9c2d0014-9e74-40b2-b452-255016c81cc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654006etomidate 20 MG in 10 ML InjectionPSN9c2d0014-9e74-40b2-b452-255016c81cc14
1654008etomidate 40 MG in 20 ML InjectionPSN9c2d0014-9e74-40b2-b452-255016c81cc14
165400610 ML etomidate 2 MG/ML InjectionSCD9c2d0014-9e74-40b2-b452-255016c81cc14
165400820 ML etomidate 2 MG/ML InjectionSCD9c2d0014-9e74-40b2-b452-255016c81cc14
1654006etomidate 20 MG per 10 ML InjectionSY9c2d0014-9e74-40b2-b452-255016c81cc14
1654008etomidate 40 MG per 20 ML InjectionSY9c2d0014-9e74-40b2-b452-255016c81cc14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65145-128-016514501280120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
65145-128-106514501281010 VIAL, SINGLE-DOSE in 1 CARTON (65145-128-10) / 20 mL in 1 VIAL, SINGLE-DOSE (65145-128-01) 2026-02-050000-00-00NoNoCurrent