Fentanyl Citrate
- Product NDC
- 0641-6289
- 11-digit product format
- 006416289
- Labeler code
- 0641
- Product ID
- 0641-6289_133a8135-0c15-44cc-86c1-5acb6819fc1a
- 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
- 2025-08-29
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fentanyl Citrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENTANYL CITRATE | 50 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MUN5LYG46H |
| Rxcui | 1735003, 1735008 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6289-01 | Fentanyl Citrate | 2 mL in 1 VIAL | INJECTION | 2 | | 3 |
| 0641-6289-25 | Fentanyl Citrate | 25 in 1 CARTON | INJECTION | 25 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0641-6289-01 | 00641628901 | 2 mL in 1 VIAL | 2 ml | | | | Historical |
| 0641-6289-25 | 00641628925 | 25 VIAL in 1 CARTON (0641-6289-25) / 2 mL in 1 VIAL (0641-6289-01) | 25 vial | 2025-08-29 | No | No | Current |