FDA.reportPublic FDA data

Etomidate

Product NDC
72485-508
11-digit product format
724850508
Labeler code
72485
Product ID
72485-508_7444860b-36c1-459d-94ba-d7301d9dc2ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etomidate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA215028
Marketing category
ANDA
Marketing start
2024-01-22
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
72485-508-01Etomidate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION102
72485-508-10Etomidate10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-508-01ML - Milliliter72485-508eabffe3e-4135-4cda-8d82-16ddc20f9ee112024-04-05
72485-508-10ML - Milliliter72485-50851ce9c07-69ea-44f9-bd17-80de804164ed12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-508ETOMIDATE INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.]2Current NDC, 2 package rows20240123_75467058-da52-48fa-8d4e-e1025ec7d461.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654006etomidate 20 MG in 10 ML InjectionPSN75467058-da52-48fa-8d4e-e1025ec7d4612
1654008etomidate 40 MG in 20 ML InjectionPSN75467058-da52-48fa-8d4e-e1025ec7d4612
165400610 ML etomidate 2 MG/ML InjectionSCD75467058-da52-48fa-8d4e-e1025ec7d4612
165400820 ML etomidate 2 MG/ML InjectionSCD75467058-da52-48fa-8d4e-e1025ec7d4612
1654006etomidate 20 MG per 10 ML InjectionSY75467058-da52-48fa-8d4e-e1025ec7d4612
1654008etomidate 40 MG per 20 ML InjectionSY75467058-da52-48fa-8d4e-e1025ec7d4612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-508-017248505080110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
72485-508-107248505081010 VIAL, SINGLE-DOSE in 1 CARTON (72485-508-10) / 10 mL in 1 VIAL, SINGLE-DOSE (72485-508-01) 2024-01-22NoNoCurrent