Ultiva
- Product NDC
- 67457-913
- 11-digit product format
- 674570913
- Labeler code
- 67457
- Product ID
- 67457-913_4e4a5266-148c-4137-8fed-74766f8c1c7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Remifentanil Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- NDA020630
- Marketing category
- NDA
- Marketing start
- 2020-04-15
- Substance
- REMIFENTANIL HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ultiva
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| REMIFENTANIL HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5V444H5WIC |
| Rxcui | 1729578, 1729581, 1729584, 1729586, 1729710, 1729712 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-913-00 | Ultiva | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 | | 4 |
| 67457-913-02 | Ultiva | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-913 | ULTIVA (REMIFENTANIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240629_4dbcb8f9-1987-4b66-bd2f-d251fda0be10.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 |
|---|
| 67457-913-00 | 67457091300 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | | Historical |
| 67457-913-02 | 67457091302 | 10 VIAL, GLASS in 1 CARTON (67457-913-02) / 5 mL in 1 VIAL, GLASS (67457-913-00) | | 2020-04-15 | 0000-00-00 | No | No | Current |