Ultiva
- Product NDC
- 72078-034
- 11-digit product format
- 720780034
- Labeler code
- 72078
- Product ID
- 72078-034_594087a1-25f2-4f68-aea6-ad7df40559ab
- 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
- 2023-06-21
- 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 |
|---|
| 72078-034-00 | Ultiva | 3 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 3 | | 5 |
| 72078-034-01 | Ultiva | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72078-034 | ULTIVA (REMIFENTANIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 4 | Current NDC, 2 package rows | 20241219_8b4c8696-e23e-4c51-a4d2-babab5bd945a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72078-034-00 | 72078003400 | 3 mL in 1 VIAL, GLASS | 3 ml | | | | Historical |
| 72078-034-01 | 72078003401 | 10 VIAL, GLASS in 1 CARTON (72078-034-01) / 3 mL in 1 VIAL, GLASS (72078-034-00) | | 2023-06-21 | No | No | Current |