Prescription drug · ANDA
Valganciclovir NDC 71921-210
Valganciclovir 50 mg/mL · Powder, For solution · Oral · Florida Pharmaceutical Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71921-210-12 | 71921021012 | 1 BOTTLE in 1 CARTON (71921-210-12) / 100 mL in 1 BOTTLEMarketed from Jul 1, 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
- Active ingredients
- Valganciclovir — 50 mg/mL
- Dosage form
- Powder, For solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216317
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 71921-210_cc6c4939-7908-439c-b1b8-6b52e826c7a5SPL ID cc6c4939-7908-439c-b1b8-6b52e826c7a5SPL set ID cc6c4939-7908-439c-b1b8-6b52e826c7a5RxCUI 863559UNII GCU97FKN3R
- 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
N471921021012followed by a unit qualifier and the quantityPackage 71921-0210-12. 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 . 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 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 is indicated for the …
Excerpt only. Read the full label for complete information.