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 |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | Fresenius Kabi USA, LLC | b45e9f1d-9c48-4b46-8541-d846b89540df | 2022-10-26 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye wash | PURIFIED WATER | McKesson | bd089fde-24ba-4de5-e053-2995a90a39bb | 2022-10-18 | Warnings | 059QF0KO0R |
| Bach Original Flower Remedies Rock Water | WATER | Nelson Bach USA Limited | ea242559-1618-3354-e053-2a95a90a1a95 | 2022-10-03 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Medical Purchasing Solutions, LLC | e90b47e3-9636-b9ee-e053-2a95a90ad48c | 2022-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| ETOMIDATE | ETOMIDATE | HF Acquisition Co LLC, DBA HealthFirst | dc43b289-4f32-1c1e-e053-2995a90a3a23 | 2022-04-09 | Warnings, Adverse reactions | 1654008 Z22628B598 |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | B. Braun Medical Inc. | 8924e52e-8622-4ed6-a061-1908183e0a18 | 2021-08-06 | Warnings, Adverse reactions | 059QF0KO0R |
| Eyewash | EYEWASH | Global Equipment Company | c4f78121-4668-2e0c-e053-2995a90ab6c6 | 2021-06-17 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Asclemed USA, Inc. | 45c38269-883c-4198-a9d5-03810a4420ec | 2021-01-14 | Warnings, Adverse reactions | 059QF0KO0R |
| Bach Original Flower Remedies | WATER | Nelson Bach USA Limited | 09c76050-42c5-4403-865c-a1f6f668d9c0 | 2020-06-15 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Baxter Healthcare Company | 8bcf5572-49e1-4302-9522-56f57904cb4a | 2019-12-29 | Warnings, Adverse reactions | 059QF0KO0R |
| Etomidate | ETOMIDATE INJECTION | Fosun Pharma USA Inc | 8b6c54d8-3f3f-4290-841c-976bea01086f | 2019-07-28 | Warnings, Adverse reactions | 1654006 1654008 Z22628B598 |
| Dynamic Eyewash with Eyecup | WATER | Dynamic Safety International | 7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2 | 2018-12-17 | Warnings | 059QF0KO0R |
| Bio Rock Water | ROCK WATER | BioActive Nutritional, Inc. | 178bd16d-0d4f-49d8-866b-8ab3a3c6889d | 2018-07-30 | Warnings | 059QF0KO0R |
| Etomidate | ETOMIDATE INJECTION | Gland Pharma Limited | 94cde4e7-3b46-419f-8dda-87675da8d89d | 2017-10-17 | Warnings, Adverse reactions | 1654006 1654008 Z22628B598 |
| Sterile Water | WATER | Baxter Healthcare Corporation | ef3e79c5-3f58-4b36-a296-64b7d9a651c1 | 2017-10-17 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.