NDC 65219-445-01 - Etomidate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65219-445
Requested NDC
65219-445-01
Package NDCs from labels
65219-445-12, 65219-445-22, 65219-445-01, 65219-445-10
Manufacturer
Fresenius Kabi USA, LLC | Caplin Steriles Limited
Effective date
2023-08-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Etomidate - Fresenius Kabi USA, LLC | Caplin Steriles LimitedFresenius Kabi USA, LLC | Caplin Steriles Limited2023-08-10HUMAN PRESCRIPTION DRUG LABEL
Etomidate - Fresenius Kabi USA, LLC | Caplin Steriles LimitedFresenius Kabi USA, LLC | Caplin Steriles Limited2023-07-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-445-01Etomidate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION105
65219-445-10Etomidate10 in 1 CARTONINJECTION, SOLUTION105
65219-445-12Etomidate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
65219-445-22Etomidate10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-445ETOMIDATE (ETOMIDATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]5Current NDC, Legacy NDC, 2 package rows20230805_d07efb9e-5264-461d-96d8-e11fa71c5751.zip
65219-445ETOMIDATE (ETOMIDATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]1Current NDC, Legacy NDC, 2 package rows20231001_f38fad46-f2dd-4692-a2a9-a13d0a717bf8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-445-01ML - Milliliter65219-445a6589a31-4bee-4ff6-b261-ab1b1bbe1b7d12021-09-07
65219-445-10ML - Milliliter65219-44527fe7089-bc43-4d07-adf1-c7c58a8bc6f512021-09-07
65219-445-12ML - Milliliter65219-4451df2c557-9485-4e04-a1ea-e9b2151ec8b712024-01-04
65219-445-22ML - Milliliter65219-4456a7eab3d-78a5-475d-ba01-3f1a25d55d4012024-01-04

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 11 of 14 · 262 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EtomidateETOMIDATEHikma Pharmaceuticals USA Inc.75bf0494-7cb9-4e8a-8edd-af62f035d2362023-12-06Warnings, Adverse reactionsExact identifier
rxcui: 1654006
rxcui: 1654008
unii: Z22628B598
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
EtomidateETOMIDATEHikma Pharmaceuticals USA Inc.4312e3c3-34de-4cb3-8abd-c24d24a4bea12023-11-20Warnings, Adverse reactionsExact identifier
rxcui: 1654006
rxcui: 1654008
unii: Z22628B598
AMIDATE(TM) ETOMIDATEAMIDATE(TM) ETOMIDATEHF Acquisition Co LLC, DBA HealthFirsta227d2f1-3eef-4ac6-e053-2995a90a53402023-10-10Warnings, Adverse reactionsExact identifier
rxcui: 1654006
unii: Z22628B598
ETOMIDATE injection, solutionETOMIDATE INJECTION, SOLUTIONHF Acquisition Co LLC, DBA HealthFirst0635683b-880a-0cd4-e063-6394a90ab73e2023-09-25Warnings, Adverse reactionsExact identifier
rxcui: 1654006
unii: Z22628B598
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.