Fentanyl Citrate
- Product NDC
- 0641-6247
- 11-digit product format
- 006416247
- Labeler code
- 0641
- Product ID
- 0641-6247_546a047c-1faf-4751-9e48-079e4c35b6fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl Citrate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA019101
- Marketing category
- NDA
- Marketing start
- 2021-03-18
- Substance
- FENTANYL CITRATE
- Active strength
- 50 ug/mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| MUN5LYG46H | FENTANYL CITRATE | 990-73-8 | FENTANYL CITRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0641-6247-25 | 00641624725 | 25 VIAL in 1 CARTON (0641-6247-25) / 1 mL in 1 VIAL (0641-6247-01) | 25 vial | 2021-03-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fentanyl Citrate | Hikma Pharmaceuticals USA Inc. | 2026-03-06 | HUMAN PRESCRIPTION DRUG LABEL | 18 |