What is NDC 65219-624?

65219-624 is the product NDC for acyclovir, Acyclovir sodium 50 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for acyclovir?

193 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

acyclovir NDC 65219-624 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-624Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0624Add 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
65219-624-20	65219062420	10 VIAL in 1 CARTON (65219-624-20) / 20 mL in 1 VIAL (65219-624-04)Marketed from Dec 16, 2024

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): acyclovir
Generic name (nonproprietary): acyclovir
Active ingredients: Acyclovir sodium — 50 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215404
Marketing start: Dec 16, 2024
Listing expires: Dec 31, 2026
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 65219-624_a2fee863-ed62-4501-881d-eab609ebd51dSPL ID a2fee863-ed62-4501-881d-eab609ebd51dSPL set ID b1bb347d-74f4-4976-8450-a375a271718fRxCUI 1734932, 1734934UNII 927L42J563UPC 0365219622024, 0365219624042
Pharmacologic class: Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor

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

N465219062420 followed by a unit qualifier and the quantity

Package 65219-0624-20. 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 Nov 13, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Herpes Simplex Infections in Immunocompromised Patients Acyclovir Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. Initial Episodes of Herpes Genitalis Acyclovir Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immuno-competent patients. Herpes Simplex Encephalitis Acyclovir Injection is indicated for the treatment of herpes simplex encephalitis. Neonatal Herpes Simplex Virus Infection Acyclovir Injection is indicated for the treatment of neonates and infants with herpes simplex infections. Varicella-Zoster Infections…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-624

What is NDC 65219-624?: 65219-624 is the product NDC for acyclovir, Acyclovir sodium 50 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: acyclovir.
What is the active ingredient?: Acyclovir sodium.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for acyclovir?: 193 other product NDCs are listed under this name. See all acyclovir 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 acyclovir NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
acyclovir	Acyclovir 50 mg/g	OintmentTopical	c	68788-4142	68788-4142-01
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0199	55154-0199-00
acyclovir	Acyclovir 800 mg/1	TabletOral	Northwind Health Company, LLC	82868-107	82868-0107-3082868-0107-35
Acyclovir	Acyclovir 50 mg/g	OintmentTopical	Aryeh Pharma Corp	85957-036	85957-0036-0185957-0036-0285957-0036-03
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Avet Pharmaceuticals Inc.	23155-962	23155-0962-0123155-0962-05
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Florida Pharmaceutical Products, LLC	71921-146	71921-0146-01
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7519	00904-7519-61
Acyclovir	Acyclovir 400 mg/1	TabletOral	Aurobindo Pharma Limited	59651-965	59651-0965-0159651-0965-0559651-0965-10
Acyclovir	Acyclovir 800 mg/1	TabletOral	Aurobindo Pharma Limited	59651-966	59651-0966-0159651-0966-0559651-0966-10
Acyclovir	Acyclovir 800 mg/1	TabletOral	REMEDYREPACK INC.	70518-4450	70518-4450-0070518-4450-01

All 194 acyclovir NDCs

Other NDCs under ANDA 215404

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

FDA NDC Directory listings under ANDA 215404
Product	Strength	Form · route	Labeler	Product NDC
acyclovir	Acyclovir sodium 50 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	65219-622