Prescription drug · ANDA
Valganciclovir (Valganciclovir hydrochloride) NDC 64380-161
Valganciclovir hydrochloride 450 mg/1 · Tablet, Film coated · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-161-01 | 6438001610164380016101 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-161-01)Marketed from Jun 16, 2025 |
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 hydrochloride
- Active ingredients
- Valganciclovir hydrochloride — 450 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200790
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 64380-161_b24a374a-e28d-4231-9664-c0401948b94fSPL ID b24a374a-e28d-4231-9664-c0401948b94fSPL set ID 89a934f0-85a3-44c1-82e5-d09d1738e08dRxCUI 313566UNII 4P3T9QF9NZUPC 0364380161011
- 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
N464380016101followed by a unit qualifier and the quantityPackage 64380-0161-01. 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 : Valganciclovir …
Excerpt only. Read the full label for complete information.
About NDC 64380-161
- What is NDC 64380-161?
- 64380-161 is the product NDC for Valganciclovir (valganciclovir hydrochloride), Valganciclovir hydrochloride 450 mg/1 tablet, film coated, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valganciclovir (Valganciclovir hydrochloride).
- What is the active ingredient?
- Valganciclovir hydrochloride.
- Who is the labeler?
- Strides Pharma Science Limited, NDC labeler code 64380. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Valganciclovir?
- 15 other product NDCs are listed under this name. See all Valganciclovir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valganciclovir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Valganciclovir | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | Micro Labs Limited | 42571-477 | 42571-0477-47 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | NorthStar RxLLC | 72603-174 | 72603-0174-01 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 450 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-973 | 42291-0973-60 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | American Health Packaging | 60687-765 | 60687-0765-13 |
| Valganciclovir | Valganciclovir 50 mg/mL | Powder, For solutionOral | Florida Pharmaceutical Products, LLC | 71921-210 | 71921-0210-12 |
| Valganciclovirvalganciclovir hydrochloride powder, | Valganciclovir hydrochloride 50 mg/mL | For solutionOral | Aurobindo Pharma Limited | 59651-444 | 59651-0444-01 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | Camber Pharmaceuticals, Inc. | 31722-837 | 31722-0837-10 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 450 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-153 | 64380-0153-01 |
| Valganciclovir | Valganciclovir hydrochloride 50 mg/mL | For solutionOral | airis PHARMA PVT LTD | 71151-003 | 71151-0003-01 |
| Valganciclovir | Valganciclovir hydrochloride 450 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-158 | 27241-0158-60 |
Other NDCs under ANDA 200790
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 |
|---|---|---|---|---|
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 450 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-973 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 450 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-153 |