Prescription drug · ANDA
Valganciclovir NDC 42571-477
Valganciclovir hydrochloride 50 mg/mL · Powder, For solution · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-477-47 | 42571047747 | 1 BOTTLE in 1 CARTON (42571-477-47) / 100 mL in 1 BOTTLEMarketed from Jun 1, 2026 |
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 — 50 mg/mL
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Micro Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218838
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 42571-477_4dab410e-74c6-a8bc-e063-6394a90a03f4SPL ID 4dab410e-74c6-a8bc-e063-6394a90a03f4SPL set ID facbcc41-52cf-4433-b3fc-9bf8f06dcdd9RxCUI 863559UNII 4P3T9QF9NZUPC 0342571477479
- 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
N442571047747followed by a unit qualifier and the quantityPackage 42571-0477-47. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Valganciclovir 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 for oral solution 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.