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 |
|---|---|---|---|---|---|---|
| Eye Wash | WATER | CVS Pharmacy | 049cee29-7ec2-4d5b-8308-f522acde43a7 | 2017-03-29 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Baxter Healthcare Company | 210dc9ab-d6ca-4552-ac19-1be17792d290 | 2016-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.