Prescription drug · ANDA
Fentanyl Citrate NDC 63323-806
Fentanyl citrate .05 mg/mL · Injection, Solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-806-01 | 63323080601 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-806-11)Marketed from May 3, 2019 | |
| 63323-806-02 | 63323080602 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-806-12)Marketed from May 3, 2019 | |
| 63323-806-05 | 63323080605 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-806-13)Marketed from May 3, 2019 | |
| 63323-806-20 | 63323080620 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-806-14)Marketed from May 3, 2019 | |
| 63323-806-50 | 63323080650 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-50) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from May 3, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — .05 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210762
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 63323-806_341b092a-1f6f-40f1-98f2-9346bf2e1242SPL ID 341b092a-1f6f-40f1-98f2-9346bf2e1242SPL set ID 38d0c14a-a0c1-44cc-a939-0304eb8037d6RxCUI 1735003, 1735007, 1735008, 1735013, 2168270UNII MUN5LYG46HUPC 0363323806132, 0363323806149, 0363323806507
- 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
N463323080601followed by a unit qualifier and the quantityPackage 63323-0806-01. 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…
Excerpt only. Read the full label for complete information.