Valganciclovir NDC 50268-787

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-787Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0787Add 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
50268-787-12	50268078712	20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-787-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-787-11)Marketed from Jul 27, 2016

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
Active ingredients: Valganciclovir hydrochloride — 450 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvPAK
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205166
Marketing start: Jul 27, 2016
Listing expires: Dec 31, 2026
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 50268-787_4745ad6c-8db3-18af-e063-6394a90a0814SPL ID 4745ad6c-8db3-18af-e063-6394a90a0814SPL set ID 85177859-e0f5-6d83-17f3-29cae1db96c3RxCUI 313566UNII 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

N450268078712 followed by a unit qualifier and the quantity

Package 50268-0787-12. 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 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Valganciclovir tablets, USP are a cytomegalovirus (CMV) nucleoside analogue 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 heart transplant patients at high risk. 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis : Valganciclovir tablets, USP are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies ( 14.1)]. Prevention of CMV Disease : Valganciclov…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205166

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

FDA NDC Directory listings under ANDA 205166
Product	Strength	Form · route	Labeler	Product NDC
Valganciclovir	Valganciclovir hydrochloride 450 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6796
Valganciclovir	Valganciclovir hydrochloride 450 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-832