AMIDATE(TM) ETOMIDATE

Product NDC
51662-1459
11-digit product format
516621459
Labeler code
51662
Product ID
51662-1459_0762982e-561c-4595-e063-6394a90a58b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMIDATE(TM) ETOMIDATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA018227
Marketing category
NDA
Marketing start
2020-03-31
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
AMIDATE(TM) ETOMIDATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETOMIDATE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ22628B598
Rxcui1654006

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
51662-1459-1AMIDATE(TM) ETOMIDATE10 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1459AMIDATE(TM) ETOMIDATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 1 package rows20231107_a227d2f1-3eef-4ac6-e053-2995a90a5340.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654006etomidate 20 MG in 10 ML InjectionPSNa227d2f1-3eef-4ac6-e053-2995a90a53402
165400610 ML etomidate 2 MG/ML InjectionSCDa227d2f1-3eef-4ac6-e053-2995a90a53402
1654006etomidate 20 MG per 10 ML InjectionSYa227d2f1-3eef-4ac6-e053-2995a90a53402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1459-15166214590110 mL in 1 VIAL, SINGLE-USE (51662-1459-1) 10 ml2020-03-310000-00-00NoNoCurrent