FDA.reportPublic FDA data

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 12 of 14 · 262 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
EtomidateETOMIDATEFresenius Kabi USA, LLCf38fad46-f2dd-4692-a2a9-a13d0a717bf82023-08-10Warnings, Adverse reactionsExact identifier
application number: ANDA215028
ndc (package): 65219-445-22
ndc (package): 65219-445-12
ndc (product): 65219-445
rxcui: 1654006
spl id: 446487f1-002e-41d3-846a-67570e797171
spl set id: f38fad46-f2dd-4692-a2a9-a13d0a717bf8
unii: Z22628B598
EtomidateETOMIDATEFresenius Kabi USA, LLCd07efb9e-5264-461d-96d8-e11fa71c57512023-07-27Warnings, Adverse reactionsExact identifier
application number: ANDA215028
ndc (package): 65219-445-10
ndc (package): 65219-445-01
ndc (package): 65219-447-20
ndc (package): 65219-447-02
ndc (product): 65219-447
ndc (product): 65219-445
ndc11 (package): 65219044501
rxcui: 1654006
rxcui: 1654008
spl id: 30488a7e-ea9e-4a27-95a9-a07149c50282
spl set id: d07efb9e-5264-461d-96d8-e11fa71c5751
unii: Z22628B598
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 6DC9Q167V3
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 6DC9Q167V3
ETOMIDATEETOMIDATEEugia US LLC0820f15a-046b-4185-a2b3-2e4051ee3d822023-07-05Warnings, Adverse reactionsExact identifier
rxcui: 1654006
rxcui: 1654008
unii: Z22628B598
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EtomidateETOMIDATEMylan Institutional LLC461e34d1-b862-4a02-9727-548c907aac482023-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1654006
rxcui: 1654008
unii: Z22628B598
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 6DC9Q167V3
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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