Prescription drug · ANDA
Valganciclovir NDC 27241-158
Valganciclovir hydrochloride 450 mg/1 · Tablet · Oral · Ajanta Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27241-158-60 | 27241015860 | 60 TABLET in 1 BOTTLE (27241-158-60)Marketed from Dec 26, 2019 |
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
- Route
- Oral
- Labeler
- Ajanta Pharma USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212234
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 27241-158_f537ddb1-f868-4bef-937b-e520b04e26a0SPL ID f537ddb1-f868-4bef-937b-e520b04e26a0SPL set ID d13cc8ad-eaf0-4ae6-89da-a850a08b1067RxCUI 313566UNII 4P3T9QF9NZUPC 0327241158605
- 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
N427241015860followed by a unit qualifier and the quantityPackage 27241-0158-60. 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 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: Valganciclovir t…
Excerpt only. Read the full label for complete information.