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 | Type |
|---|---|---|---|
| Etomidate - Fresenius Kabi USA, LLC | Caplin Steriles Limited | Fresenius Kabi USA, LLC | Caplin Steriles Limited | 2023-08-10 | HUMAN PRESCRIPTION DRUG LABEL |
| Etomidate - Fresenius Kabi USA, LLC | Caplin Steriles Limited | Fresenius Kabi USA, LLC | Caplin Steriles Limited | 2023-07-27 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65219-445-01 | Etomidate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 5 | |
| 65219-445-10 | Etomidate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 5 | |
| 65219-445-12 | Etomidate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 1 | |
| 65219-445-22 | Etomidate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65219-445 | ETOMIDATE (ETOMIDATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230805_d07efb9e-5264-461d-96d8-e11fa71c5751.zip |
| 65219-445 | ETOMIDATE (ETOMIDATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ] | 1 | Current NDC, Legacy NDC, 2 package rows | 20231001_f38fad46-f2dd-4692-a2a9-a13d0a717bf8.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65219-445-01 | ML - Milliliter | 65219-445 | a6589a31-4bee-4ff6-b261-ab1b1bbe1b7d | 1 | 2021-09-07 |
| 65219-445-10 | ML - Milliliter | 65219-445 | 27fe7089-bc43-4d07-adf1-c7c58a8bc6f5 | 1 | 2021-09-07 |
| 65219-445-12 | ML - Milliliter | 65219-445 | 1df2c557-9485-4e04-a1ea-e9b2151ec8b7 | 1 | 2024-01-04 |
| 65219-445-22 | ML - Milliliter | 65219-445 | 6a7eab3d-78a5-475d-ba01-3f1a25d55d40 | 1 | 2024-01-04 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Thompson Safety Eyewash | WATER | Thompson Safety | 1d0e96cf-245b-cfb7-e063-6294a90a4ced | 2024-07-12 | Warnings | 059QF0KO0R |
| Eyesaline Emergency Eyewash | PURIFIED WATER | Honeywell Safety Products USA, Inc. | ad42a7e3-84ea-390d-e053-2a95a90a3a32 | 2024-06-14 | Warnings | 059QF0KO0R |
| Eyes Alive Eye Wash | WATER | RIVIERA PHARMA INC | 081079f4-1c06-4054-b771-00fedaa666f6 | 2024-06-05 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Becton Dickinson and Company | 6e43c5a3-dad2-49ed-b500-964cb4563cc9 | 2024-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Enviroclenz | BERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM | Deseret Biologicals, Inc. | 92816bbe-96d6-45fc-9929-d3e6df394a33 | 2024-05-02 | Warnings | 6DC9Q167V3 |
| PEMF Optimizer | AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 97d57469-4c5b-4d3f-9398-3a1a6617a649 | 2024-04-23 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Hikma Pharmaceuticals USA Inc. | 78ef7ad3-451d-43d0-a9b6-5cf0aadca003 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | B. Braun Medical Inc. | 8fc8d87a-3951-4ac5-97df-c161ffc90475 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye Wash | WATER | M-star (Hubei) Health&Care Products Co., Ltd. | 71706039-e250-4f08-9687-71b2928c4e46 | 2024-04-01 | Warnings | 059QF0KO0R |
| Etomidate | ETOMIDATE | Civica, Inc. | 98002094-f065-4b5f-963f-2c34b5241316 | 2024-03-31 | Warnings, Adverse reactions | 1654006 1654008 Z22628B598 |
| Envirotox | TRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM. | BioActive Nutritional, Inc. | 2b5cfdba-cf4d-4eb0-8c60-20eac6922663 | 2024-03-26 | Warnings | 6DC9Q167V3 |
| ULINE Eyewash | EYEWASH | Uline. | 14545fc9-1fb4-befa-e063-6294a90a0474 | 2024-03-23 | Warnings | 059QF0KO0R |
| GI Drainage | CINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOS | Deseret Biologicals, Inc. | ff81e3ca-2f88-4daf-a734-083107269d3a | 2024-02-21 | Warnings | 059QF0KO0R |
| Sterile Water | STERILE WATER | Chartwell RX, LLC | 3681eeaa-807a-47ca-9fbc-61c2b682800a | 2024-02-01 | 059QF0KO0R | |
| Sterile Water | WATER | A-S Medication Solutions | dba87371-31d2-47c2-ab83-89aabce4b184 | 2024-01-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Etomidate | ETOMIDATE | Armas Pharmaceuticals Inc. | 75467058-da52-48fa-8d4e-e1025ec7d461 | 2024-01-22 | Warnings, Adverse reactions | ANDA215028 1654006 1654008 Z22628B598 |
| F02 ANGR-FLX | ADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLE | Apex Energetics Inc. | bc7c2bf3-8b0d-766f-e053-2a95a90ad34c | 2024-01-08 | Warnings | 059QF0KO0R |
| F09 LTGO | ADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALIS | Apex Energetics Inc. | bd1e652f-b3a4-c5bd-e053-2995a90ae03f | 2024-01-08 | Warnings | 059QF0KO0R |
| Fendall 2000 Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | b56ef662-fec2-4d94-e053-2995a90aba2b | 2024-01-06 | Warnings | 059QF0KO0R |
| Harris Teeter Ultra Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Harris Teeter, LLC. | 31ac6883-ffc6-39de-e063-6294a90a52dd | 2024-01-01 | Warnings | 6DC9Q167V3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.