ETOMIDATE injection, solution

Product NDC
51662-1634
11-digit product format
516621634
Labeler code
51662
Product ID
51662-1634_0635683b-880b-0cd4-e063-6394a90ab73e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ETOMIDATE injection, solution
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA206126
Marketing category
ANDA
Marketing start
2023-09-25
Substance
ETOMIDATE
Active strength
20 mg/10mL
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 injection, solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETOMIDATE20 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ22628B598
Rxcui1654006

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
fe0c5d6c-1467-3506-5566-aee700997367Product name520210610

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1634-1ETOMIDATE injection, solution10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1634ETOMIDATE INJECTION, SOLUTION INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]1Current NDC, 1 package rows20230926_0635683b-880a-0cd4-e063-6394a90ab73e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654006etomidate 20 MG in 10 ML InjectionPSN0635683b-880a-0cd4-e063-6394a90ab73e1
165400610 ML etomidate 2 MG/ML InjectionSCD0635683b-880a-0cd4-e063-6394a90ab73e1
1654006etomidate 20 MG per 10 ML InjectionSY0635683b-880a-0cd4-e063-6394a90ab73e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1634-15166216340110 mL in 1 VIAL, SINGLE-DOSE (51662-1634-1) 10 ml2023-09-25NoNoCurrent