Amidate
- Product NDC
- 0409-6695
- 11-digit product format
- 004096695
- Labeler code
- 0409
- Product ID
- 0409-6695_3f83ed21-1b60-486c-8c70-1d5aa7553404
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ETOMIDATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- NDA018227
- Marketing category
- NDA
- Marketing start
- 2005-07-26
- Substance
- ETOMIDATE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- General Anesthesia [PE], General Anesthetic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amidate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETOMIDATE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z22628B598 |
| Rxcui | 1654006, 1654008, 1654009, 1654011 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-6695-01 | Amidate | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 27 |
| 0409-6695-02 | Amidate | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 27 |
| 0409-6695-11 | Amidate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 27 |
| 0409-6695-12 | Amidate | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 20 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETOMIDATE | ACTIVE INGREDIENT | Z22628B598 | AMIDATE (ETOMIDATE) INJECTION, SOLUTION AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| ETOMIDATE | ACTIVE MOIETY | Z22628B598 | AMIDATE (ETOMIDATE) INJECTION, SOLUTION AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | AMIDATE (ETOMIDATE) INJECTION, SOLUTION AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | AMIDATE (ETOMIDATE) INJECTION, SOLUTION AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-6695 | AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.] | 26 | Current NDC, Legacy NDC, 4 package rows | 20241210_b7ed5bf8-ba75-44dc-8f81-96b4ad5766be.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 |
|---|
| 0409-6695-01 | 00409669501 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-6695-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-6695-11) | | 2005-07-26 | 0000-00-00 | No | No | Current |
| 0409-6695-02 | 00409669502 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-6695-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-6695-12) | | 2005-09-08 | 0000-00-00 | No | No | Current |
| 0409-6695-11 | 00409669511 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 0409-6695-12 | 00409669512 | 20 mL in 1 VIAL, SINGLE-DOSE | 20 ml | | | | | Historical |