Remifentanil Hydrochloride
- Product NDC
- 63323-723
- 11-digit product format
- 633230723
- Labeler code
- 63323
- Product ID
- 63323-723_2f27e51f-2b55-47ee-bd4a-001b71c60622
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Remifentanil Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA206223
- Marketing category
- ANDA
- Marketing start
- 2018-01-19
- 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 |
|---|
| 63323-723-01 | Remifentanil Hydrochloride | 3 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 3 | | 6 |
| 63323-723-03 | Remifentanil Hydrochloride | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 6 |
| 63323-723-04 | Remifentanil Hydrochloride | 3 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 3 | | 3 |
| 63323-723-06 | Remifentanil Hydrochloride | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-723 | REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241027_d2374b84-81c9-44f9-a4a9-1071281b2531.zip |
| 63323-723 | REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250309_5b8025d2-3424-477b-9cff-3990a98c2a65.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 |
|---|
| 63323-723-01 | 63323072301 | 3 mL in 1 VIAL, SINGLE-DOSE | 3 ml | | | | | Historical |
| 63323-723-03 | 63323072303 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-723-03) / 3 mL in 1 VIAL, SINGLE-DOSE (63323-723-01) | | 2018-01-19 | 0000-00-00 | No | No | Current |
| 63323-723-04 | 63323072304 | 3 mL in 1 VIAL, SINGLE-DOSE | 3 ml | | | | | Historical |
| 63323-723-06 | 63323072306 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-723-06) / 3 mL in 1 VIAL, SINGLE-DOSE (63323-723-04) | | 2018-01-19 | 0000-00-00 | No | No | Current |