Prescription drug · NDA
Fentanyl Citrate NDC 0641-6248
Fentanyl citrate 50 ug/mL · Injection · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6248-10 | 00641624810 | 10 SYRINGE, GLASS in 1 CARTON (0641-6248-10) / 1 mL in 1 SYRINGE, GLASS (0641-6248-01)Marketed from Feb 1, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fentanyl Citrate
- Generic name (nonproprietary)
- fentanyl citrate
- Active ingredients
- Fentanyl citrate — 50 ug/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019101
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0641-6248_546a047c-1faf-4751-9e48-079e4c35b6faSPL ID 546a047c-1faf-4751-9e48-079e4c35b6faSPL set ID ce5db1c2-feb1-4ad2-847a-d02e865bd47eRxCUI 1735003, 1735007, 1735008, 1735013, 2168270, 2474269, 2629337UNII MUN5LYG46H
- Pharmacologic class
- Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400641624810followed by a unit qualifier and the quantityPackage 00641-6248-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Fentanyl Citrate Injection is indicated for: analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. use as a narcotic analgesic supplement in general or regional anesthesia. administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. Fentanyl Citrate Injection is indicated for: an…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 019101
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6028 |
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6027 |
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6029 |
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6030 |
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6247 |
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6289 |
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6249 |
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6290 |
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntramuscular, Intravenous | Phlow Corp. | 81565-205 |
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-171 |
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-170 |
| Fentanyl Citrate | Fentanyl citrate 50 ug/mL | InjectionIntravenous | Civica, Inc. | 72572-172 |