Etomidate
- Product NDC
- 65219-447
- 11-digit product format
- 652190447
- Labeler code
- 65219
- Product ID
- 65219-447_30488a7e-ea9e-4a27-95a9-a07149c50282
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etomidate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA215028
- Marketing category
- ANDA
- Marketing start
- 2021-08-01
- Substance
- ETOMIDATE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- General Anesthesia [PE], General Anesthetic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Etomidate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETOMIDATE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z22628B598 |
| Rxcui | 1654006, 1654008 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-447-02 | Etomidate | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 20 | | 5 |
| 65219-447-20 | Etomidate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-447 | ETOMIDATE (ETOMIDATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230805_d07efb9e-5264-461d-96d8-e11fa71c5751.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65219-447-02 | 65219044702 | 20 mL in 1 VIAL, SINGLE-DOSE | 20 ml | | | | | Historical |
| 65219-447-20 | 65219044720 | 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-447-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-447-02) | | 2021-08-01 | 0000-00-00 | No | No | Current |