What is NDC 81565-205?

81565-205 is the product NDC for Fentanyl Citrate, Fentanyl citrate 50 ug/mL injection, listed with the FDA by Phlow Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.

Phlow Corp., NDC labeler code 81565. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fentanyl Citrate?

17 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fentanyl Citrate NDC 81565-205 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)81565-205Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81565-0205Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
81565-205-02	8156502050281565020502	25 VIAL in 1 CARTON (81565-205-02) / 2 mL in 1 VIAL (81565-205-01)Marketed from Jan 11, 2023

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 — 50 ug/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Phlow Corp.NDC labeler code 81565
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019101
Marketing start: Jan 11, 2023
Marketing end: Jun 30, 2028
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 81565-205_09e32400-24f3-4cab-9563-30e9f92dc17dSPL ID 09e32400-24f3-4cab-9563-30e9f92dc17dSPL set ID 58dcd3f7-e3d8-4929-a186-8f680a51ff11RxCUI 1735003UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N481565020502 followed by a unit qualifier and the quantity

Package 81565-0205-02. 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 Dec 23, 2025. 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.

Full label on DailyMed (opens in a new tab)

About NDC 81565-205

What is NDC 81565-205?: 81565-205 is the product NDC for Fentanyl Citrate, Fentanyl citrate 50 ug/mL injection, listed with the FDA by Phlow Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fentanyl Citrate.
What is the active ingredient?: Fentanyl citrate.
Who is the labeler?: Phlow Corp., NDC labeler code 81565. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fentanyl Citrate?: 17 other product NDCs are listed under this name. See all Fentanyl Citrate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fentanyl Citrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6289	00641-6289-25
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6290	00641-6290-01
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6248	00641-6248-10
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6249	00641-6249-10
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6247	00641-6247-25
Fentanyl Citrate	Fentanyl citrate 100 ug/2mL	Injection, SolutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-810	63323-0810-20
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntravenous	Civica, Inc.	72572-172	72572-0172-01
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	Injection, SolutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-808	63323-0808-11
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Civica, Inc.	72572-170	72572-0170-25
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Civica, Inc.	72572-171	72572-0171-10

All 18 Fentanyl Citrate NDCs

Other NDCs under NDA 019101

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 019101
Product	Strength	Form · route	Labeler	Product NDC
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6027
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6028
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.	0641-6248
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6249
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6289
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6290
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Civica, Inc.	72572-170
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntramuscular, Intravenous	Civica, Inc.	72572-171
Fentanyl Citrate	Fentanyl citrate 50 ug/mL	InjectionIntravenous	Civica, Inc.	72572-172