Amidate
- Product NDC
- 0404-9811
- 11-digit product format
- 004049811
- Labeler code
- 0404
- Product ID
- 0404-9811_53c329b0-76c1-42c8-96d3-f01088ce5bd8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etomidate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- NDA018227
- Marketing category
- NDA
- Marketing start
- 2022-01-06
- 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
- Amidate
- 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, 1654009 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9811-10 | Amidate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 6 |
| 0404-9811-10 | Amidate | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9811 | AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240324_eb63c7d7-5eca-4751-be51-45cf4d7715aa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9811-10 | 00404981110 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9811-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2022-01-06 | 0000-00-00 | No | No | Current |