Valganciclovir NDC 60687-765

NDC codes

FDA NDC Directory

Product NDC (as listed)60687-765Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60687-0765Add 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
60687-765-13	60687076513	1 BOTTLE, GLASS in 1 CARTON (60687-765-13) / 100 mL in 1 BOTTLE, GLASSMarketed from Aug 20, 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): Valganciclovir
Generic name (nonproprietary): valganciclovir hydrochloride
Active ingredients: Valganciclovir hydrochloride — 50 mg/mL
Dosage form: Powder, For solution
Route: Oral
Labeler: American Health Packaging
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211475
Marketing start: Aug 20, 2023
Listing expires: Dec 31, 2026
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 60687-765_038956dc-dd87-2583-e063-6294a90aa282SPL ID 038956dc-dd87-2583-e063-6294a90aa282SPL set ID 0e30509f-add6-43c8-9e1d-e10c55a207e6RxCUI 863559UNII 4P3T9QF9NZUPC 0360687765136
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

N460687076513 followed by a unit qualifier and the quantity

Package 60687-0765-13. 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 Aug 22, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Valganciclovir is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients (1.1) Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients (1.2) Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir for oral solution is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1) ]. Prevention of CMV Disease: Valganciclovir for…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211475

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

FDA NDC Directory listings under ANDA 211475
Product	Strength	Form · route	Labeler	Product NDC
Valganciclovirvalganciclovir hydrochloride	Valganciclovir hydrochloride 50 mg/mL	Powder, For solutionOral	Camber Pharmaceuticals, Inc.	31722-837
Valganciclovirvalganciclovir hydrochloride	Valganciclovir hydrochloride 50 mg/mL	Powder, For solutionOral	NorthStar RxLLC	72603-174

Valganciclovir (valganciclovir hydrochloride) NDC 60687-765