REMIFENTANIL HYDROCHLORIDE
- Product NDC
- 0143-9391
- 11-digit product format
- 001439391
- Labeler code
- 0143
- Product ID
- 0143-9391_5c5e498b-d829-4f78-bcca-466631014767
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- REMIFENTANIL HYDROCHLORIDE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA210594
- Marketing category
- ANDA
- Marketing start
- 2021-05-15
- 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
- REMIFENTANIL HYDROCHLORIDE
- 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, 1729584, 1729710 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9391-01 | REMIFENTANIL HYDROCHLORIDE | 3 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 3 | | 4 |
| 0143-9391-10 | REMIFENTANIL HYDROCHLORIDE | 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 |
|---|
| 0143-9391 | REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240312_9d289052-1eb6-4ba2-a3ca-d2e542a052ae.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 |
|---|
| 0143-9391-01 | 00143939101 | 3 mL in 1 VIAL | 3 ml | | | | | Historical |
| 0143-9391-10 | 00143939110 | 10 VIAL in 1 CARTON (0143-9391-10) / 3 mL in 1 VIAL (0143-9391-01) | 10 vial | 2021-05-15 | 0000-00-00 | No | No | Current |