AMIDATE(TM) ETOMIDATE

Product NDC
51662-1455
11-digit product format
516621455
Labeler code
51662
Product ID
51662-1455_9f42e2ee-41b5-a215-e053-2995a90a01a4
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
2019-12-12
Marketing end
0000-00-00
Substance
ETOMIDATE
Active strength
2 mg/mL
Pharmacologic classes
General Anesthesia [PE],General Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fe0c5d6c-1467-3506-5566-aee700997367Product name520210610

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1455-12025-01-30C16284748780-12cef2736-8c1a-d83d-e063-dadaa90ab31fAMIDATE(TM) ETOMIDATE INJECTION, USP 40mg/20mL (2mg/mL) 20mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1455-1AMIDATE(TM) ETOMIDATE20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1455AMIDATE(TM) ETOMIDATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Legacy NDC, 1 package rows20200224_99847797-99eb-40d4-e053-2995a90a972a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654008etomidate 40 MG in 20 ML InjectionPSN99847797-99eb-40d4-e053-2995a90a972a2
165400820 ML etomidate 2 MG/ML InjectionSCD99847797-99eb-40d4-e053-2995a90a972a2
1654008etomidate 40 MG per 20 ML InjectionSY99847797-99eb-40d4-e053-2995a90a972a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1455-15166214550120 mL in 1 VIAL, SINGLE-DOSE (51662-1455-1) 20 ml2019-12-120000-00-00NoNoCurrent