Valganciclovir hydrochloride for Oral NDC 0591-2579

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-2579Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-2579Add 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
0591-2579-20	00591257920	100 mL in 1 BOTTLE, GLASS (0591-2579-20)Marketed from Aug 26, 2016

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): Valganciclovir hydrochloride for Oral
Generic name (nonproprietary): valganciclovir hydrochloride
Active ingredients: Valganciclovir hydrochloride — 50 mg/mL
Dosage form: Powder, For solution
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205220
Marketing start: Aug 26, 2016
Listing expires: Dec 31, 2027
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 0591-2579_1bd0c81a-d232-4345-b920-7941c7594198SPL ID 1bd0c81a-d232-4345-b920-7941c7594198SPL set ID 92281301-5fb5-4eea-8766-4863e241c234RxCUI 863559UNII 4P3T9QF9NZ
Pharmacologic class: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor; Nucleoside Analog Antiviral

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400591257920 followed by a unit qualifier and the quantity

Package 00591-2579-20. 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 Jun 25, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Valganciclovir for oral solution is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Pediatric Patients ( 1.2 ) Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.2 Pediatric Patients Prevention of CMV Disease: Valganciclovir is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies ( 14.2 )] .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205220

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

FDA NDC Directory listings under ANDA 205220
Product	Strength	Form · route	Labeler	Product NDC
Valganciclovir hydrochloride for Oralvalganciclovir hydrochloride	Valganciclovir hydrochloride 50 mg/mL	Powder, For solutionOral	AvKARE	42291-972