Prescription drug · ANDA
Valganciclovir Hydrochloride NDC 65862-753
Valganciclovir hydrochloride 450 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-753-01 | 65862075301 | 100 TABLET in 1 BOTTLE (65862-753-01)Marketed from Mar 31, 2016 | |
| 65862-753-05 | 65862075305 | 500 TABLET in 1 BOTTLE (65862-753-05)Marketed from Mar 31, 2016 | |
| 65862-753-18 | 65862075318 | 180 TABLET in 1 BOTTLE (65862-753-18)Marketed from Mar 31, 2016 | |
| 65862-753-60 | 65862075360 | 60 TABLET in 1 BOTTLE (65862-753-60)Marketed from Mar 31, 2016 | |
| 65862-753-99 | 65862075399 | 1000 TABLET in 1 BOTTLE (65862-753-99)Marketed from Mar 31, 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 Hydrochloride
- Generic name (nonproprietary)
- valganciclovir hydrochloride
- Active ingredients
- Valganciclovir hydrochloride — 450 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204750
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 65862-753_3d5cd566-06ab-4e83-aba8-f692ff8a23ddSPL ID 3d5cd566-06ab-4e83-aba8-f692ff8a23ddSPL set ID 8d2ffc05-2fbc-41f8-8656-fbc0bfa7ad83RxCUI 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
N465862075301followed by a unit qualifier and the quantityPackage 65862-0753-01. 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 tablets are 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 are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1) ] . Prevention of CMV Disease: Valganciclovi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204750
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Valganciclovir Hydrochloride | Valganciclovir hydrochloride 450 mg/1 | TabletOral | NorthStar Rx LLC | 72603-750 |