REMIFENTANIL HYDROCHLORIDE
- Product NDC
- 68475-507
- 11-digit product format
- 684750507
- Labeler code
- 68475
- Product ID
- 68475-507_c6bfa062-45c2-460c-a923-b551732fa4af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- REMIFENTANIL HYDROCHLORIDE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Navinta LLC
- Application
- ANDA210594
- Marketing category
- ANDA
- Marketing start
- 2021-01-01
- Marketing end
- 0000-00-00
- Substance
- REMIFENTANIL HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68475-507-02 | 68475050702 | 10 VIAL in 1 CARTON (68475-507-02) > 10 mL in 1 VIAL | 10 vial | 2021-01-01 | 0000-00-00 | No | No | Current |